14MG+abnormal+issue+report

为了帮助大家更好的理解欧盟法规要求，本文根据MEDDEV2.12∙1rev8医疗器械警戒系统指南，翻译整理了不良事件和市场纠正措施(FSCA)的案例，供大家学习使用。

备注：如下案例仅作示例之用，为制造商确定是否需要报告给主管当局提供指南。

示例目的是说明报告决定应基于相当多的考量因素。

如有歧义，请以英文指南为准。

不良事件示例O1病患在使用除颤器后死亡，且有证据表明除颤器存在问题。

A.需要报告B.不需要报告C.视情况而定A02按照制造商的使用说明，病患接受外科透热治疗，在使用中产生了灼伤。

A.需要报告B.不需要报告C.视情况而定C如果灼伤明显，应报告。

因为这是正常预期外的严重健康损伤。

03由于输液泵故障，输液泵停止了工作，但未能发出适当的报警，无病患因此而受伤。

A.需要报告B.不需要报告C.视情况而定A因为如果相同的场景再次发生，此问题可能会引发了严重的健康损害。

04因输液泵与使用的输液器间的不匹配，导致输注剂量错误。

A.需要报告B.不需要报告C.视情况而定C若此组合使用符合输液泵或输液器(两者任一)的使用说明，则此事件应报告。

05因对器械的不当操作导致主动脉球囊导管泄漏，使患者处于潜在的危险处境之中。

A.需要报告B.不需要报告C.视情况而定C如果该不当操作是由标签信息不充分导致的，此事件应报告。

06导管在插入过程中断裂，没有操作不当的迹象。

断裂发生的位置使断裂的部分很容易取出。

A.需要报告B.不需要报告C.视情况而定A因为这显然是一个幸运的情况，如果导管在一个稍微不同的位置断裂，就需要外科手术来取回断裂的一端。

07用户发现装隐形眼镜的小瓶中有玻璃颗粒。

A.需要报告B.不需要报告C.视情况而定A08起搏器寿命到期后感应失效。

择期更换指数(ER1)没有及时显示，根据设备规格说明它应该显示。

A.需要报告B.不需要报告C.视情况而定A09病患在接受X射线血管造影系统检查中，X射线血管造影系统的C形臂运动不受控制,病人被影像增强器击中，鼻子骨折。

Form code: MED 201.NORRevision: 2017-07Page 1 of 4Certificate No: MEDB00005BKApplication of: Directive 2014/90/EU of 23 July 2014 on marine equipment (MED), issued as "Forskrift om Skipsutstyr" by the Norwegian Maritime Authority. This Certificate is issued by DNV GL AS under the authority of the Government of Norway.This is to certify:That the Equivalent fixed gas fire extinguishing systems components (extinguishing medium, head valves and nozzles) for machinery spaces and cargo pump roomswith type designation(s) NOVEC ECS 500Issued toKidde-Fenwal, Inc.Ashland, MA , USAis found to comply with the requirements in the following Regulations/Standards: item No. MED/3.45. SOLAS 74 as amended Regulation II-2/10 & X/3, IMO MSC/Circ. 848, IMO MSC.1/Circ.1313, FSS Code 5 and 2000 HSC Code 7Further details of the equipment and conditions for certification are given overleaf.This Certificate is valid until 2025-09-10.Issued at Høvik on 2020-09-11DNV GL local station:Certification & Inspection ServicesApproval Engineer: Helge BjørnaråNotified Body No.:0575for DNV GL ASRoald Vårheim Head of Notified BodyThe mark of conformity may only be affixed to the above type approved equipment and a Manufacturer’s Declaration of Conformit y issued when the production-surveillance module (D, E or F) of Annex B of the MED is fully complied with and controlled by a written inspection agreement with a Notified Body. The product liability rests with the manufacturer or his representative in accordance with Directive 2014/90/EU.This certificate is valid for equipment, which is conform to the approved type. The manufacturer shall inform DNV GL AS of any changes to the approved equipment. This certificate remains valid unless suspended, withdrawn, recalled or cancelled.Should the specified regulations or standards be amended during the validity of this certificate, the product is to be re-approved before being placed on board a vessel to which the amended regulations or standards apply.Digitally Signed By: Hoff, Øyvind Location: DNV GL Høvik, Norwayon behalf ofJob Id: 344.1-009310-1Certificate No: MEDB00005BK Product description“Novec ECS 500”,is a fixed gas fire extinguishing system using fire extinguishing agent Novec 1230 stored in steel cylinders as liquid and pressurized with nitrogen and distributed through pipes and nozzles.The extinguishing concentration and nozzles are covered by this type approval certificate. Documentation for the other system components shall be submitted and approved for each project. The system is to be designed in accordance with IMO MSC/Circ.848 as amended by IMO MSC.1/Circ.1267 and IMO MSC.1/Circ.1316.The extinguishing agent, Novec 1230, is produced by 3M, Cordova, Illinois, USA.2)When calculated at 20°C. Ambient temperature to be determined case by case for each project3)NFPA 2001 (2008 Edition)The following associated companies are authorised by Kidde-Fenwal to apply this certificate: -Kidde-Fenwal Inc., Ashland, USA-Kidde Fire Protection, Stokenchurch, UKApplication/LimitationThe design gas concentration (diesel) shall be minimum 5.85% (applied on a net volume) and the maximum agent discharge time shall be 10 seconds. The extinguishing system shall be designed and installed according to SOLAS Ch. II-2, IMO MSC/Circ.848 as amended by IMO MSC.1/Circ.1267, IMO MSC.1/Circ.1316 and the Kidde manual.The following additional limitations will apply:A.Novec ESC 500 systems are not suitable for the ship’s cargo holds. If Novec ESC 500 systemsare installed inside cargo pump rooms, all components shall be certified for use in hazardousareas, the design gas concentration shall be increased and the system is subjected to case bycase approval.B.If Novec 1230 agent is used above its NOAEL (calculated on net volume at max expectedambient temperature), means should be provided to limit exposure (IMO MSC.1/Circ.1267, 6).In no case should Novec 1230 be used in concentrations above its LOAEL.C.Steel storage cylinders of size 10 lb (4.5 kg) to 900 lb (408 kg). Cylinders being 81 L or larger isonly accepted when arrangements are provided on board to ensure that cylinders can be easily moved (even to shore) for service and recharging. All cylinders shall be of the same size.D.Gas cylinders shall be delivered on board with a product certificate of the Society or with acertificate issued by a recognized certification authority according to national regulations based on the requirements of the design standard and marked accordingly π, UN or DOT.E.Cylinders are topped up with nitrogen to 34.5 bar (500 psi) at 21°C. The fill density shall bemaximum 1.12 kg/L. Cylinders are to be delivered with DNV product certificate or equivalentcertificates acceptable to the flag administration and class.F.Cylinders to be located in a separate room in accordance with SOLAS Ch. II-2 Reg. 10.4.3, ordistributed throughout the protected space in accordance with the requirements in IMOMSC/Circ.848 item 11 as amended by IMO MSC.1/Circ.1267. When distributed within theprotected space, the min extinguishing concentration (after any single failure) shall be 4.5 %.Job Id: 344.1-009310-1Certificate No: MEDB00005BKponents in the system will be regarded under pressure class II with a maximum designpressure of 40 bar (at 54 °C). Consideration will though be made for piping and couplings inside the protected space.H.The nozzles are to be located in accordance with the Kidde manual. A basic rule is that onenozzle can as a maximum cover an area of 5 m x 10 m. A 360° nozzle shall be located centrally in this area, the 180° nozzles on the sides (as applicable). The maximum cover height is 5 m.The minimum average nozzle pressure is 4.2 bar.I.Bilges (except open bilges in small volume engine rooms) are to be protected with a dedicatednozzle network.The following documentation is to be submitted to the flag administration in each case:1.Plans showing location of cylinders, piping, nozzles and release stations as well as the assembledsystem2.Capacity calculations, including hydraulic flow calculations.3.Plans defining release lines and alarm system.4.Material specification and dimensions for piping and specifications for all other components.5.Ship specific release procedures and post discharge ventilation procedures.6.Manual containing design, inspection, operation and maintenance procedures.7.Control arrangements for closure of openings and stop of fans and any pressure relief devices asper IMO MSC/Circ. 848, 13. These plans can also be supplied by yard.Testing at installations and periodical surveys-The system shall be tested as per maker’s manual both at installations and at periodical surveys, except that DNV do not require monthly content check of cylinders. The minimum test pressure is minimum 53 bar for any closed sections, whereas open section shall be tightness tested atminimum 7 bar.-The system is subject to biennual (every 2nd year) inspections by an approved service supplier.The attending surveyor will also apply requirement relevant for flag administration and / or class on newbuilding and ship in operation surveys.Type Examination documentationDesign, Installation, Operation and Maintenance Manual – Novec ECS 500, No. P/N 06-237589-001, dated May 2017 from Kidde.Report No. HAI Project #5087, dated 28 June 2002, from Hughes Associates, Inc., Baltimore, USA. (tested on U.S. Coast Guard’s Fire & Safety Test Detachment in Mobile, AL).Report No. 04-CRADA-RDC-001, dated 16 November 2004, from Kidde-Fenwal Inc., Massachusetts, USA. (tested on U.S. Coast Guard’s Fire & Safety Test Detachment in Mobile, AL, witnessed by UL).Test Report File EX4674, Project 04NK23160, dated 1 February 2005, from UL, Northbook, USA.Report No. 3026502, dated 24 March 2006, from FM Approvals, Norwood, USA.Test report File EX4674, project 4788267101, dated 30 March 2018, from UL, Northbook, USAKidde Fenwal component sheets, stamped July 2005.Tests carried outTested in accordance with IMO MSC/Circ.848 as amended by IMO MSC.1/Circ.1267 and MSC.1/Circ.1316.Job Id: 344.1-009310-1Certificate No: MEDB00005BK Marking of productMain components in the system are to be marked with name and address of manufacturer, type designation and Mark of Conformity (see first page).。

境外不良反应报告规范与使用指南下载提示：该文档是本店铺精心编制而成的，希望大家下载后，能够帮助大家解决实际问题。

文档下载后可定制修改，请根据实际需要进行调整和使用，谢谢！本店铺为大家提供各种类型的实用资料，如教育随笔、日记赏析、句子摘抄、古诗大全、经典美文、话题作文、工作总结、词语解析、文案摘录、其他资料等等，想了解不同资料格式和写法，敬请关注！Download tips: This document is carefully compiled by this editor. I hope that after you download it, it can help you solve practical problems. The document can be customized and modified after downloading, please adjust and use it according to actual needs, thank you! In addition, this shop provides you with various types of practical materials, such as educational essays, diary appreciation, sentence excerpts, ancient poems, classic articles, topic composition, work summary, word parsing, copy excerpts, other materials and so on, want to know different data formats and writing methods, please pay attention!I. 简介在药品上市后，为了确保患者用药的安全性和有效性，需要对药品的不良反应进行监测和报告。

质量处罚通报模板范文Mass Penalty Report Template.Purpose: To document the mass penalty issued to a vendor for failing to meet the contractual weight requirements.Reporting Party: [Your Name]Date: [Date]Vendor Name: [Vendor Name]Contract Number: [Contract Number]Item Description: [Item Description]Contractual Weight Requirement: [Contractual Weight Requirement]Actual Weight: [Actual Weight]Mass Penalty: [Mass Penalty]Penalty Calculation:The mass penalty was calculated based on the following formula:Mass Penalty = (Contractual Weight Actual Weight) Unit Price Penalty Factor.Unit Price: [Unit Price]Penalty Factor: [Penalty Factor]Total Penalty Amount: [Total Penalty Amount]Rationale:The vendor failed to meet the contractual weight requirement for the specified item. As a result, the vendoris subject to a mass penalty as per the terms of the contract.Supporting Documentation:The following supporting documentation is attached to this report:Copy of the contract.Weighing ticket.Inspection report.Actions Required:The vendor is required to take the following actions:Review the mass penalty and ensure that the weight discrepancy is corrected.Submit a corrective action plan to prevent futureweight discrepancies.Pay the mass penalty in full by [Due Date].Consequences of Non-Compliance:Failure to comply with the requirements of this mass penalty report may result in additional penalties, including termination of the contract.中文回答：质量处罚通报模板范文。

RoHS承诺书两篇篇一：RoHS承诺书尊敬的客户：我司郑重声明：自年月日起，所有由我司提供给贵司的产品，符合欧盟RoHS环保指令的要求。

我司承诺，在未得到贵司采购部门的书面同意之前，绝不提供不符合欧盟RoHS 指令要求的产品，若我司私自将不符合欧盟RoHS指令要求的产品发给贵司，我司将立即以书面形式通知贵司，并在贵司要求时间内补交符合指令要求的产品进行更换，并承担相应的责任，包括贵司客户方的索赔。

作为贵司的供应商，我司乐于提供必要的文件或信息以证明我们的产品符合上述条款，若我们发现产品有违反上述内容，将停止对贵司的供货。

RoHS六种有害物质的建议含量要求为，铅 (Pb) 0.1%（1000ppm）镉（Cd） 0.01% (100ppm)汞（Hg） 0.1%（1000ppm）六价铬 0.1%（1000ppm）有机溴化物多溴联苯类PBB 0.1%（1000ppm）多溴二苯醚PBDE 0.1%（1000ppm）若指令有变化，我司将提供满足新要求的产品给贵司。

公司名称：公司地址：公司授权代表签字（加盖公章）：承诺日期：篇二：热缩管等绝缘套管ROHS2.0承诺书为适应市场和客户的环保要求，加强对环保物料的品质控制和过程控制，规范供货行为，保证向客户供应的产品、部件或材料等均符合本承诺书中的要求，任何未达到承诺书中要求而造成的损失均由供应商负全部责任并进行相应的赔偿，特此制定此承诺书。

1.总则自承诺书签定日开始所提热缩管呢等绝缘套管产品，保证满足以下要求。

我方保证产品中环保控制指标为：a 镉（Cd）含量小于70ppm；b 铅(Pb)、汞(Hg)、六价铬(Cr（VI）)、多溴联苯（PBBs）、多溴二苯醚（PBDEs）、邻苯二甲酸二丁酯（DBP）、邻苯二甲酸丁苄酯（BBP）、邻苯二甲酸二（2-乙基己基）酯（DEHP）、邻苯二甲酸二异丁酯（DIBP）含量小于800ppm；c 豁免材料中：铜合金中的铅含量小于38000ppm；2.具体条款供应的所有物料均满足ROHS 2.0(修正指令EU 2015/863)要求并保证满足以下条款：2.1样品承认阶段，供方需提交：有效期内的RoHS 2.0(修正指令EU 2015/863)第三方(SGS或CTI)测试报告（中、英文版）。

异常类别(Abnormalfication)检验者(Owner):单位主管(Supervisor):发文编号(CAR NO):发生日(Date):2017/11/15 进料(Inlet Material)供应商(Supplier):重庆XX 制程(Process)材料编号 (Material no):CNJ-0003部品名称(Part Name)PE袋 来料总数(Out totality)20000PCS 抽检数量200PCS 不良数(Rejection number)200PCS 不良率((Rejection rate)100.00%负责人预计完成日期(Responsible)(Anticipated Duedate)填写者(Owner):主管审核Supervisor:确认者Owner:单位主管Supervisor:结案者(Owner):结案审核(ClosedLSS-F-04-028-A04.改善对策(Countermeasure):7.结案资料确认说明 (Confirmation of CAR Close)：结案日期( Closed Date):针对供应商之矫正预防措施及对策审查，确认其是否結案.Based on reviewing the vendor’s countermeasure and verifying its effectiveness for CAR closure.6.效果确认 (Confirmed Results of Corrective Actions )：周xx 1.更新制袋机作业指导书，将切刀温度设定区间更新为180℃-183℃；【见SOP更新】2.更新检验基准书，增加堆叠状态下的外观检查内容，确保无遗漏。

【见SIP更新】1.冻结全部库存，经查无在途产品，我司库存5000PCS，均有不同程度的毛边存在，经重工合格后再入库；2.与客户协商到客户处重工处置不良品，已于2014-11-18完成客户端20000PCS的重工处理。

MGB麦德龙验厂标准MGB METRO Group Buying HK LimitedSelf Assessment Report 自我评审报告MGB Reference No.: _____________________Supplier Name(供应商)Supplier Code(供应商编码)Factory Name(工厂)Factory Address(工厂地址)Property of MGB HK Limited. MGB HK 2010 All right reserved. Factory Self Assessment Template_Ver#100507R1 Page 1 of 17MGB METRO Group Buying HK LimitedSelf Assessment Report 自我评审报告MGB Reference No.: _____________________Factory Site Information(工厂信息)Ownership (private, public, belonging to group)所有关系(私营、集体所有、归属于集团)Year of establishment (in current legal document) 成立时间(以最近的法律文件为准)Organization Chart of Factory 工厂组织结构Products Manufactured (产品)Products for MGB (生产的MGB产品)Production Capacity (monthly/ annual Qty)产能(月产量)Manufacturing Premises (Sq M/ Sq Ft)生产场地(平方米/平方英尺) Machine/Equipment used (no. of units) 使用的机器设备(每款数量)Employees Details (no. of people) 员工信息(员工数量)Supervisors/Managers (管理者/经理)Administration (行政人员)Quality Control (品管)Engineering (技术人员)Design & Development (研发人员)Permanent Workers (固定员工人数)Temporary Workers (流动员工)Grand Total(总计)Working Hour (how many shift, from when to when?)工作时间(几班,具体从几点到几点)No. of subcontractors used (转包商数量)Property of MGB HK Limited. MGB HK 2010 All right reserved. Factory Self Assessment Template_Ver#100507R1 Page 2 of 17MGB METRO Group Buying HK LimitedSelf Assessment Report 自我评审报告MGB Reference No.: _____________________Name & process of main 无subcontractors)主要转包商的名字及具体工作)Property of MGB HK Limited. MGB HK 2010 All right reserved. Factory Self Assessment Template_Ver#100507R1 Page 3 of 17MGB METRO Group Buying HK LimitedSelf Assessment Report 自我评审报告MGB Reference No.: _____________________Section 1: General Organization StructureItem Question Result RemarkYes No N/A1.1 Does the factory have the up to dateorganizational chart? If yes, please attach a copy of organization chart.是否有最新的组织结构图,如有,请提供一份组织结构图。

EU RoHS新增禁用四項可塑劑不使用證明書
歐盟於2015年6月4日正式公告RoHS（recast）指令(2011/65/EU) 禁用物質清單（Annex II）新增下列四項鄰苯二甲酸酯：
•鄰苯二甲酸二(2-乙基己基)酯(DEHP) (0,1 %)
•鄰苯二甲酸丁酯苯甲酯(BBP) (0,1 %)
•鄰苯二甲酸二丁酯(DBP) (0,1 %)
•鄰苯二甲酸二異丁酯(DIBP) (0,1 %)
執行日期為2019年7月22日（醫療設備和監控儀器2021年7月22日）
自即日起為宣告期，但至2018年底止，本公司會強制要求所有有業務往來之供應商所供應給本公司之材料均須符合Rohs2的標準，確定符合Rohs2之材料，須提供第三方認證之檢測報告上傳至本公司GPM系統，以確保2019年起本公司出給客人的貨品是完全符合歐盟Rohs2的標準。

茲證明關於向貴公司交貨的零部件、輔助材料及裝置零部件的使用材料、包裝材料以及生產工程中的添加劑等，無EU RoHS新增禁用四項可塑劑之禁用物質。

公司名稱/廠商編號：
公司住址：
負責人姓名/職稱/簽章：
E-mail/Tel No:
產品名稱/全能料號:
保證提交日期:
備註：。