MEDDEV-2[1].12-1-rev-6-附录-中英文1248.pdf

附件3 制造商向国家主管当局提交报告格式表 ANNEX 3 REPORT FORM FOR MANUFACTURERS TO THE NATIONAL COMPETENT AUTHORITY Manufacturers Incident Report 制造商事故报告 医疗器械警戒系统（MEDDEV 2.12/1 rev 6）1 行政信息 Administrative information 接收者 Recipient 国家主管当局名称 Name of National Competent Authority(NCA)国家主管当局地址 Address of National competent Authority 主管当局盖章 Stamp box for the Competent Authority(6040 mm)该报告的时间 Date of this report 制造商指定的参考号码 Reference number assigned by the manufacturer 国家主管当局指定的接收者索引号码（若已知）Reference number assigned by NCA to whom sent(if known)报告类型 Type of report 初始报告 Initial report 跟踪报告 Follow-up report 包含初始和最终的联合报告 Combined Initial and final report 最终报告 Final report 事件是否构成严重危害公众健康 Does the incident represent a serious public health threat?是 Yes 否 No Classification of incident 事故类型 死亡 death 健康状况的严重损坏，严重公共健康威胁 unanticipated serious deterioration instate of health 其他所有可报告事故 ALL other reportable incidents 确定该报告的其他发送国家主管当局 Identify to what other NCAs this report was also sent 2 报告提交人信息 Information on submitter of the report 发送人身份 Status of submitter 制造商 Manufacturer EEA 和瑞士内授权代表 Authorised Representative within EEA and Switzerland 其他（请表明其身份）Others:(identify the role)3 制造商信息 Manufacturer information 制造商名称 Manufacturer name 制造商联系人 Manufacturers contact person 地址 Address 邮政编码 Postal code 城市 City 电话 Phone 传真 Fax 电子邮件 E-mail 国家 Country 2)4 授权代表信息 Authorized Representative information 授权代表名称 Name of the Authorized Representative 授权代表联系人 The Authorized Representatives contact person 地址 Address 邮政编码 Postal code 城市 City 电话 Phone 传真 Fax 电子邮件 E-mail 国家 Country 2)5 报告提交者信息（如果不同于第 3、4 节）Submitters information(if different from section 3 or 4)提交者姓名 submitters name 联系人姓名 Name of the contact person 地址 Address 邮政编码 Postal code 城市 City 电话 Phone 传真 Fax 电子邮件 E-mail 国家 Country 2)6 医疗器械信息 Medical device information 分类 Class 有源植入类 AIMD Active implants MDD 法规规定第 类 MDD Class IVD 附件列表 A IVD Annex List A MDD 法规规定第类 MDD Class b IVD 附件列表 B IVD Annex List B MDD 分类 a MDD Class a IVD 自测诊断器械 IVD Devices for self-testing MDD 分类 MDD Class IVD 一般 IVD General 分类系统(最好是 GMDN)Nomenclature system(preferable GMDN)分类系统代号 Nomenclature code 分类内容 Nomenclature text 商品名/品牌名/制造者 Commercial name/brand name/make 型号 Mode and/or 编号 catalogue number 序列(适用时)号 Serial number(s)（if applicable）批号 lot/batch number(s)软件版本号(适用时)Software version number(if applicable)制造日期 Device Manufacturing date,失效期 Expiry date 附件/随附器械(适用时)Accessories/associated device(if applicable)公告机构识别号码 Notified Body(NB)ID-number 7 事故信息 Incident information 使用点报告参考号码,适用时 User facility report reference number,if applicable 制造商知悉日期 Manufacturers awareness date 事故发生日期 Date the incident occurred 事故描述 Incident description narrative 涉及病人数量(若知)Number of patients involved(if known)涉及器械数量(若知)Number of medical devices involved(if known)医疗器械现处地点(若知)Medical device current location/disposition(if known)事故发生时医疗器械的使用者 Operator of the medical device at the time of incident(select one)健康护理专家 health care professional 病人 patient 其他 other 医疗器械的使用者(请选择)Usage of the medical device(select from list below)初次使用 initial use 一次性器械的重复使用 reuse of a single use medical device 可重复使用器械的再次使用 reuse of a reusable medical device 修复后使用/维修 re-serviced/refurbished 其他(请详述)other(please specify)使用前注意到问题 problem noted prior use 8 病人信息 Patient information 事故发生后病人状况 patient outcome 有关的健康护理点采取的补救措施 Remedial action taken by the healthcare facility relevant to the care of the patient 事故发生时病人的年龄,适用时 Age of the patient at the time of incident,if applicable 性别,适用时 Gender,if applicable 女性 Female 男性 Male 重量,适用时 Weight in kilograms,if applicable 9 健康护理点信息 Healthcare facility information 健康护理点名称 Name of the health care facility 护理点内联系人 Contact person within the facility 地址 Address 邮政编码 Postal code 城市 City 电话 Phone 传真 Fax 电子邮件 E-mail 国家 Country 2)10 制造商初始意见(初次/跟踪报告)Manufacturers preliminary comments (Initial/Follow-up report)制造商初始分析 Manufacturers preliminary analysis 制造商采取的初始纠正预防措施 Initial corrective actions/preventive actions implemented by the manufacturer 下次预计报告日期 Expected date of next report 11 制造商末次调查结果(末次报告)Results of manufacturers final investigation(Final report)制造商器械分析结果 Results of manufacturers final investigation(Final report)制造商器械分析结果 The manufacturers device analysis results 补救措施/纠正措施/预防措施/市场安全纠正措施 Remedial action/corrective action/preventive action/Field safety Corrective Action 注意：NOTE:提交这个市场安全纠正措施需要填附表 4 In the case of a FSCA the submitter needs to fill in the form of Annex 4 确定采取的措施时间表 Time schedule for the implementation of the identified actions 制造商末次评估报告 Final comments from the manufacturer 进一步调查 Further investigations 制造商有无意识到同型器械中因同类原因造成的同类事故?Is the manufacturer aware of similar incidents with this type of medical device with a similar root cause?是 Yes 否 No 类似事件的数量 Number of similar incidents 如果是,请表明在何国家和事故报告索引号.If yes,stare in which countries and the report reference numbers of the incidents.仅对末次报告适用:医疗器械被分布到下列国家内:For Final Report only:The medical device has been distributed to the following countries:-在 EEA 和瑞士内:-Within the EEA and Switzerland:AT BE BU CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MT NL NO PL PT RO SE SI SK-候补国家-Candidate Countries CR TR 所有 EEA-,候补国家和瑞士 ALL EEA-,Candidate Countries and Switzerland -其他:-others:12 评价 Comments 本人保证就本人所掌握的知识范围,上述信息是正确的。I affirm that the information given above is correct to the best of my knowledge.签名 Signature 姓名 Name：城市 City:日期 Date:Submission of this report does not,in itself,represent a conclusion by the manufacturer and/or authorized representative or the National Competent Authority that the content of this report is complete or accurate,that the medical device(S)caused or contributed to the alleged death or deterioration the state of the health of any person.本报告的提交本身并不代表制造商和或其授权代表或国家主管当局对本报告的内容完整或准确的结论，也不代表所列医疗器械的任何错误和或医疗器械引起或促成了宣称的任何人的死亡或其健康六况的严重损坏。附录 4 欧洲市场安全纠正措施 ANNEX 4 EUROPEAN FIELD SAFETY CORRECTIVE ACTION REPORT FORM 医疗器械警戒系统(MEDDEV 2.12/1 rev 5)1 行政信息 Administrative information 送达地 Destination 国家主管当局名称 Name of National Competent Authority(NCA)国家主管当局地址 Address of National competent Authority 主管当局盖章 Stamp box for the Competent Authority(6040 mm)该报告的时间 Date of this report 制造商指定索引号 Reference number assigned by the manufacturer 事故索引号及协作国家主管当局名称（适用时）Incident reference number and name of the co-ordinating NCA Competent Authority(if applicable)确定该报告的其它发送国家主管当局 Identify to what other Competent Authorities this report was also sent 2 报告提交人信息 Information on submitter of the report 发送人身份 Status of submitter 制造商 Manufacturer EEA 内授权代表 Authorised Representative within EEA 其他（请表明其身份）Others:(identify the role)3 制造商信息 Manufacturer information 制造商名称 Manufacturer name 制造商联系人 Manufacturers contact person 地址 Address 邮政编码 Postal code 城市 City 电话 Phone 传真 Fax 电子邮件 E-mail 国家 Country 2)4 授权代表信息 Authorized Representative information 授权代表名称 Name of the Authorized Representative 授权代表联系人 The Authorized Representatives contact person 地址 Address 邮政编码 Postal code 城市 City 电话 Phone 传真 Fax 电子邮件 E-mail 国家 Country 2)5 国家联络点信息 National contact point information 国家联络点名称 National contact point name 联系人姓名 Name of the contact person 地址 Address 邮政编码 Postal code 城市 City 电话 Phone 传真 Fax 电子邮件 E-mail 国家 Country 2)6 医疗器械信息 Medical device information 分类 Class 有源植入类 AIMD Active implants MDD 法规规定第 类 MDD Class IVD 附件列表 A IVD Annex List A MDD 法规规定第类 MDD Class b IVD 附件列表 B IVD Annex List B MDD 分类 a MDD Class a IVD 自测诊断器械 IVD Devices for self-testing MDD 分类 MDD Class IVD 一般 IVD General 分类系统(最好是 GMDN)Nomenclature system(preferable GMDN)分类系统代号 Nomenclature code 分类内容 Nomenclature text 商品名/品牌名/制造者 Commercial name/brand name/make 型号 Mode and/or 序列号/批号 Serial number(s)or lot/batch number(s)软件版本号(适用时)Software version number(if applicable)制造日期/失效期 Device Manufacturing date/Expiry date 附件/随附器械(适用时)Accessories/associated device(if applicable)公告机构识别号码 Notified Body(NB)ID-number 7 市场安全纠正措施描述 Description of FSCA 市场安全纠正措施背景信息和原因 Background information and reason for the FSCA 描述措施及其理由（纠正/预防）Description and justification of the action(corrective/preventive)分销商和使用者对所采取措施的建议 Advice on actions to be taken by the distributor and the user.附加资料 Attached please find 英文版市场安全公告 Field Safety Notice(FSN)in English 国语版市场安全公告 FSN in national language 其它（请详述）Others(please specify)在 EEA 和瑞士内受市场安全纠正措施影响的国家：These countries within the EEA and Switzerland are affected by this FSCA:-在 EEA 和瑞士内-within the EEA and Switzerland AT BE BU CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MT NL NO PL PT RO SE SI SK-候补国家-Candidate Countries CR TR 所有 EEA-,候补国家和瑞士 ALL EEA-,Candidate Countries and Switzerland -其他:-others:EEA 和瑞士范围之外受市场纠正措施影响的国家 These countries outside the EEA and Switzerland are affected by this FSCA:8 备注 Comments 本人保证就本人所掌握的知识范围,上述信息是正确的。I affirm that the information given above is correct to the best of my knowledge.签名 Signature 姓名 Name：城市 City:日期 Date Submission of this report does not,in itself,represent a conclusion by the manufacturer and/or authorized representative or the National Competent Authority that the content of this report is complete or accurate,that the medical device(S)caused or contributed to the alleged death or deterioration the state of the health of any person.本报告的提交本身并不代表制造商和或其授权代表或国家主管当局对本报告的内容完整或准确的结论，也不代表所列医疗器械的任何错误和或医疗器械引起或促成了宣称的任何人的死亡或其健康六况的严重损坏。