|
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) 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 |
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 |
|
|
