发布时间 : 星期一 文章MEDDEV 2[1].12-1 rev 6 附录 中英文更新完毕开始阅读12691fc20c22590102029d6e
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 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 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 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