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制造商知悉日期Manufacturers awareness date |
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事故發生日期Date the incident occurred |
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事故描述Incident description narrative |
涉及病人數量(若知 )Number of patients involved (if known)
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涉及器械數量(若知) Number of medical devices involved (if known) |
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醫療器械現處地點(若知)Medical device current location/disposition(if known) |
事故發生時醫療器械的使用者Operator of the medical device at the time of incident(select one)
□ 健康護理專家health care professional □ 病人patient
□ 其他other |
醫療器械的使用者(請選擇)Usage of the medical device (select from list below)
□ 初次使用initial use
□ 一次性器械的重復使用reuse of a single use medical device
□ 可重復使用器械的再次使用reuse of a reusable medical device
□ 修復后使用/維修 re-serviced/refurbished
□ 其他(請詳述)other(please specify)
□ 使用前注意到問題problem noted prior use |
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8病人信息Patient information |
事故發生后病人狀況patient outcome
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有關的健康護理點采取的補救措施Remedial action taken by the healthcare facility relevant to the care of the patient
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事故發生時病人的年齡,適用時Age of the patient at the time of incident, if applicable
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性別,適用時Gender, if applicable
□ 女性Female □ 男性Male |
重量,適用時Weight in kilograms, if applicable
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9 健康護理點信息Healthcare facility information |
健康護理點名稱Name of the health care facility
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護理點內聯系人Contact person within the facility
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地址Address |
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郵政編碼 Postal code |
城市City |
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電話Phone |
傳真Fax |
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電子郵件E-mail |
國家Country 2) |
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10 制造商初始意見(初次/跟蹤報告) Manufacturer’s preliminary comments (Initial/Follow-up report) |
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制造商初始分析Manufacturer’s preliminary analysis |
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制造商采取的初始糾正預防措施Initial corrective actions/preventive actions implemented by the manufacturer |
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下次預計報告日期Expected date of next report |
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11 制造商末次調查結果(末次報告) Results of manufacturers final investigation (Final report) |
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制造商器械分析結果Results of manufacturers final investigation(Final report) |
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制造商器械分析結果The manufacturer’s device analysis results |
補救措施/糾正措施/預防措施/市場安全糾正措施Remedial action/corrective action/preventive action/Field safety Corrective Action
注意：NOTE: 提交這個市場安全糾正措施需要填附表4 In the case of a FSCA the submitter needs to fill in the form of Annex 4
確定采取的措施時間表Time schedule for the implementation of the identified actions |
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制造商末次評估報告Final comments from the manufacturer |
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進一步調查Further investigations |
制造商有無意識到同型器械中因同類原因造成的同類事故?Is the manufacturer aware of similar incidents with this type of medical device with a similar root cause?
□ 是Yes □ 否No |
類似事件的數量Number of similar incidents
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如果是,請表明在何國家和事故報告索引號.If yes, stare in which countries and the report reference numbers of the incidents.
僅對末次報告適用:醫療器械被分布到下列國家內:For Final Report only: The medical device has been distributed to the following countries:
-在EEA和瑞士內:-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
-候補國家-Candidate Countries □CR □TR
□所有EEA-, 候補國家和瑞士 □ALL EEA-,Candidate Countries and Switzerland
-其他:-others: |
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12 評價Comments |
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