MEDDEV - 2.12-1附录3：制造商事故报告

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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 MANUFACTURER’S TO THE NATIONAL COMPETENT AUTHORITY Manufacturer’s 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 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 主管当局盖章Stamp box for the Competent Authority (～60×40 mm) 2 报告提交人信息 Information on submitter of the report

本资料由药智网整理，查看更多资料敬请登陆bbs.yaozh.com(也可用新浪微博账号登陆） 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Manufacturer’s contact person 地址Address 邮政编码 Postal code 电话Phone 电子邮件E-mail 城市City 传真Fax 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 Representative’s contact person 地址Address 邮政编码 Postal code 电话Phone 电子邮件E-mail 城市City 传真Fax 国家Country 2) 5 报告提交者信息（如果不同于第3、4节） Submitter’s information (if different from section 3 or 4) 提交者姓名submitter’s name 联系人姓名Name of the contact person 地址Address 邮政编码 Postal code 电话Phone 城市City 传真Fax

本资料由药智网整理，查看更多资料敬请登陆bbs.yaozh.com(也可用新浪微博账号登陆） 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Ш类 MDD Class Ш □ IVD 附件Ⅱ列表A IVD AnnexⅡ List A □ MDD法规规定第Ⅱ类 MDD Class Ⅱb □ IVD 附件Ⅱ列表B IVD AnnexⅡ List B □ MDD分类 Ⅱa MDD Class Ⅱa □ IVD自测诊断器械 IVD Devices for self-testing □ MDD分类 MDD ClassⅠ □ 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(适用时)号Serial number(s) （if applicable） 编号 catalogue number 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

本资料由药智网整理，查看更多资料敬请登陆bbs.yaozh.com(也可用新浪微博账号登陆） 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

本资料由药智网整理，查看更多资料敬请登陆bbs.yaozh.com(也可用新浪微博账号登陆） 护理点内联系人Contact person within the facility 地址Address 邮政编码 Postal code 电话Phone 电子邮件E-mail 城市City 传真Fax 国家Country 2) 10 制造商初始意见(初次/跟踪报告) Manufacturer’s preliminary comments (Initial/Follow-up report) 制造商初始分析Manufacturer’s 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 manufacturer’s device analysis results

本资料由药智网整理，查看更多资料敬请登陆bbs.yaozh.com(也可用新浪微博账号登陆） 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。

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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

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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 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 主管当局盖章Stamp box for the Competent Authority (～60×40 mm) 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Manufacturer’s contact person 地址Address 邮政编码 Postal code 电话Phone 电子邮件E-mail 城市City 传真Fax 国家Country 2)

本资料由药智网整理，查看更多资料敬请登陆bbs.yaozh.com(也可用新浪微博账号登陆） 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 Representative’s contact person 地址Address 邮政编码 Postal code 电话Phone 电子邮件E-mail 城市City 传真Fax 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 电话Phone 电子邮件E-mail 城市City 传真Fax 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Ш类 MDD Class Ш □ IVD 附件Ⅱ列表A IVD AnnexⅡ List A □ MDD法规规定第Ⅱ类 MDD Class Ⅱb □ IVD 附件Ⅱ列表B IVD AnnexⅡ List B □ MDD分类 Ⅱa MDD Class Ⅱa □ IVD自测诊断器械 IVD Devices for self-testing □ MDD分类 MDD ClassⅠ □ 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

本资料由药智网整理，查看更多资料敬请登陆bbs.yaozh.com(也可用新浪微博账号登陆） 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) …

本资料由药智网整理，查看更多资料敬请登陆bbs.yaozh.com(也可用新浪微博账号登陆） 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。

本资料由药智网整理，查看更多资料敬请登陆bbs.yaozh.com(也可用新浪微博账号登陆） 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。

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