MEDDEV21121rev6附錄中英文

1、附件3 制造商向國(guó)家主管當(dāng)局提交報(bào)告格式表 ANNEX 3 REPORT FORM FOR MANUFACTURERS TO THE NATIONAL COMPETENT AUTHORITYManufacturers Incident Report制造商事故報(bào)告醫(yī)療器械警戒系統(tǒng)（MEDDEV 2.12/1 rev 6）1 行政信息 Administrative information接收者Recipient國(guó)家主管當(dāng)局名稱Name of National Competent Authority(NCA)國(guó)家主管當(dāng)局地址Address of National competent Authorit

2、y主管當(dāng)局蓋章Stamp box for the Competent Authority (60×40 mm)該報(bào)告的時(shí)間Date of this report制造商指定的參考號(hào)碼Reference number assigned by the manufacturer國(guó)家主管當(dāng)局指定的接收者索引號(hào)碼（若已知）Reference number assigned by NCA to whom sent (if known)報(bào)告類型Type of report 初始報(bào)告Initial report 跟蹤報(bào)告Follow-up report 包含初始和最終的聯(lián)合報(bào)告Combined Ini

3、tial and final report 最終報(bào)告Final report事件是否構(gòu)成嚴(yán)重危害公眾健康Does the incident represent a serious public health threat?是Yes否NoClassification of incident事故類型 死亡death 健康狀況的嚴(yán)重?fù)p壞，嚴(yán)重公共健康威脅unanticipated serious deterioration instate of health 其他所有可報(bào)告事故ALL other reportable incidents確定該報(bào)告的其他發(fā)送國(guó)家主管當(dāng)局Identify to what

4、 other NCAs this report was also sent2 報(bào)告提交人信息 Information on submitter of the report發(fā)送人身份Status of submitter 制造商Manufacturer EEA 和瑞士?jī)?nèi)授權(quán)代表 Authorised Representative within EEA and Switzerland 其他（請(qǐng)表明其身份）Others: (identify the role)3 制造商信息 Manufacturer information制造商名稱Manufacturer name制造商聯(lián)系人Manufacture

5、rs contact person地址Address郵政編碼 Postal code城市City電話Phone傳真Fax電子郵件E-mail國(guó)家Country 2)4 授權(quán)代表信息 Authorized Representative information授權(quán)代表名稱Name of the Authorized Representative授權(quán)代表聯(lián)系人The Authorized Representatives contact person地址Address郵政編碼 Postal code城市City電話Phone傳真Fax電子郵件E-mail國(guó)家Country 2)5 報(bào)告提交者信息（如果

6、不同于第3、4節(jié)） Submitters information (if different from section 3 or 4)提交者姓名submitters name聯(lián)系人姓名Name of the contact person地址Address郵政編碼 Postal code城市City電話Phone傳真Fax電子郵件E-mail國(guó)家Country 2)6 醫(yī)療器械信息 Medical device information分類Class 有源植入類AIMD Active implants MDD法規(guī)規(guī)定第類 MDD Class IVD 附件列表A IVD Annex List A M

7、DD法規(guī)規(guī)定第類 MDD Class b IVD 附件列表B IVD Annex List B MDD分類 a MDD Class a IVD自測(cè)診斷器械 IVD Devices for self-testing MDD分類 MDD Class IVD一般 IVD General分類系統(tǒng)(最好是GMDN) Nomenclature system (preferable GMDN)分類系統(tǒng)代號(hào)Nomenclature code分類內(nèi)容Nomenclature text商品名/品牌名/制造者Commercial name/brand name/make型號(hào) Mode and/or編號(hào) catalo

8、gue number序列(適用時(shí))號(hào)Serial number(s) （if applicable）批號(hào) lot/batch number(s)軟件版本號(hào)(適用時(shí)) Software version number (if applicable)制造日期 Device Manufacturing date, 失效期Expiry date附件/隨附器械(適用時(shí)) Accessories/associated device (if applicable)公告機(jī)構(gòu)識(shí)別號(hào)碼 Notified Body (NB) ID-number7 事故信息Incident information使用點(diǎn)報(bào)告參考號(hào)碼,適

9、用時(shí)User facility report reference number, if applicable制造商知悉日期Manufacturers awareness date事故發(fā)生日期Date the incident occurred事故描述Incident description narrative涉及病人數(shù)量(若知 )Number of patients involved (if known)涉及器械數(shù)量(若知) Number of medical devices involved (if known)醫(yī)療器械現(xiàn)處地點(diǎn)(若知)Medical device current locat

10、ion/disposition(if known)事故發(fā)生時(shí)醫(yī)療器械的使用者Operator of the medical device at the time of incident(select one) 健康護(hù)理專家health care professional 病人patient 其他other醫(yī)療器械的使用者(請(qǐng)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(fù)使用reuse of a single use medical device 可重復(fù)使用器械的再次使用reuse

11、of a reusable medical device 修復(fù)后使用/維修 re-serviced/refurbished 其他(請(qǐng)?jiān)斒?other(please specify) 使用前注意到問(wèn)題problem noted prior use8病人信息Patient information事故發(fā)生后病人狀況patient outcome有關(guān)的健康護(hù)理點(diǎn)采取的補(bǔ)救措施Remedial action taken by the healthcare facility relevant to the care of the patient事故發(fā)生時(shí)病人的年齡,適用時(shí)Age of the patien

12、t at the time of incident, if applicable性別,適用時(shí)Gender, if applicable 女性Female 男性Male重量,適用時(shí)Weight in kilograms, if applicable9 健康護(hù)理點(diǎn)信息Healthcare facility information健康護(hù)理點(diǎn)名稱Name of the health care facility護(hù)理點(diǎn)內(nèi)聯(lián)系人Contact person within the facility地址Address郵政編碼 Postal code城市City電話Phone傳真Fax電子郵件E-mail國(guó)家Co

13、untry 2)10 制造商初始意見(jiàn)(初次/跟蹤報(bào)告) Manufacturers preliminary comments (Initial/Follow-up report)制造商初始分析Manufacturers preliminary analysis制造商采取的初始糾正預(yù)防措施Initial corrective actions/preventive actions implemented by the manufacturer下次預(yù)計(jì)報(bào)告日期Expected date of next report11 制造商末次調(diào)查結(jié)果(末次報(bào)告) Results of manufacturers

14、 final investigation (Final report)制造商器械分析結(jié)果Results of manufacturers final investigation(Final report)制造商器械分析結(jié)果The manufacturers device analysis results補(bǔ)救措施/糾正措施/預(yù)防措施/市場(chǎng)安全糾正措施Remedial action/corrective action/preventive action/Field safety Corrective Action注意：NOTE: 提交這個(gè)市場(chǎng)安全糾正措施需要填附表4 In the case of

15、a FSCA the submitter needs to fill in the form of Annex 4確定采取的措施時(shí)間表Time schedule for the implementation of the identified actions制造商末次評(píng)估報(bào)告Final comments from the manufacturer進(jìn)一步調(diào)查Further investigations制造商有無(wú)意識(shí)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

16、device with a similar root cause? 是Yes 否No類似事件的數(shù)量Number of similar incidents如果是,請(qǐng)表明在何國(guó)家和事故報(bào)告索引號(hào).If yes, stare in which countries and the report reference numbers of the incidents.僅對(duì)末次報(bào)告適用:醫(yī)療器械被分布到下列國(guó)家內(nèi):For Final Report only: The medical device has been distributed to the following countries:-在EEA和瑞士

17、內(nèi):-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(bǔ)國(guó)家-Candidate Countries CR TR所有EEA-, 候補(bǔ)國(guó)家和瑞士 ALL EEA-,Candidate Countries and Switzerland -其他:-others:12 評(píng)價(jià)Comments本人保證就本人所掌握的知識(shí)范圍,上述信息是正確的。I affirm that the information gi

18、ven above is correct to the best of my knowledge.簽名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, tha

19、t the medical device(S) caused or contributed to the alleged death or deterioration the state of the health of any person.本報(bào)告的提交本身并不代表制造商和或其授權(quán)代表或國(guó)家主管當(dāng)局對(duì)本報(bào)告的內(nèi)容完整或準(zhǔn)確的結(jié)論，也不代表所列醫(yī)療器械的任何錯(cuò)誤和或醫(yī)療器械引起或促成了宣稱的任何人的死亡或其健康六況的嚴(yán)重?fù)p壞。附錄4 歐洲市場(chǎng)安全糾正措施ANNEX 4 EUROPEAN FIELD SAFETY CORRECTIVE ACTION REPORT FORM醫(yī)療器械警戒系統(tǒng)(MED

20、DEV 2.12/1 rev 5)1 行政信息 Administrative information送達(dá)地Destination國(guó)家主管當(dāng)局名稱Name of National Competent Authority(NCA)國(guó)家主管當(dāng)局地址Address of National competent Authority主管當(dāng)局蓋章Stamp box for the Competent Authority (60×40 mm)該報(bào)告的時(shí)間Date of this report制造商指定索引號(hào)Reference number assigned by the manufacturer事故索

21、引號(hào)及協(xié)作國(guó)家主管當(dāng)局名稱（適用時(shí)）Incident reference number and name of the co-ordinating NCA Competent Authority (if applicable)確定該報(bào)告的其它發(fā)送國(guó)家主管當(dāng)局Identify to what other Competent Authorities this report was also sent2 報(bào)告提交人信息 Information on submitter of the report發(fā)送人身份Status of submitter 制造商Manufacturer EEA內(nèi)授權(quán)代表 Aut

22、horised Representative within EEA 其他（請(qǐng)表明其身份）Others: (identify the role)3 制造商信息 Manufacturer information制造商名稱Manufacturer name制造商聯(lián)系人Manufacturers contact person地址Address郵政編碼 Postal code城市City電話Phone傳真Fax電子郵件E-mail國(guó)家Country 2)4 授權(quán)代表信息 Authorized Representative information授權(quán)代表名稱Name of the Authorized R

23、epresentative授權(quán)代表聯(lián)系人The Authorized Representatives contact person地址Address郵政編碼 Postal code城市City電話Phone傳真Fax電子郵件E-mail國(guó)家Country 2)5 國(guó)家聯(lián)絡(luò)點(diǎn)信息 National contact point information國(guó)家聯(lián)絡(luò)點(diǎn)名稱 National contact point name聯(lián)系人姓名Name of the contact person地址Address郵政編碼 Postal code城市City電話Phone傳真Fax電子郵件E-mail國(guó)家Count

24、ry 2)6 醫(yī)療器械信息 Medical device information分類Class 有源植入類AIMD Active implants MDD法規(guī)規(guī)定第類 MDD Class IVD 附件列表A IVD Annex List A MDD法規(guī)規(guī)定第類 MDD Class b IVD 附件列表B IVD Annex List B MDD分類 a MDD Class a IVD自測(cè)診斷器械 IVD Devices for self-testing MDD分類 MDD Class IVD一般 IVD General分類系統(tǒng)(最好是GMDN) Nomenclature system (pre

25、ferable GMDN)分類系統(tǒng)代號(hào)Nomenclature code分類內(nèi)容Nomenclature text商品名/品牌名/制造者Commercial name/brand name/make型號(hào) Mode and/or序列號(hào)/批號(hào)Serial number(s) or lot/batch number(s) 軟件版本號(hào)(適用時(shí)) Software version number (if applicable)制造日期/失效期Device Manufacturing date/Expiry date附件/隨附器械(適用時(shí)) Accessories/associated device (if

26、 applicable)公告機(jī)構(gòu)識(shí)別號(hào)碼 Notified Body (NB) ID-number7 市場(chǎng)安全糾正措施描述Description of FSCA市場(chǎng)安全糾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（糾正/預(yù)防）Description and justification of the action (corrective/preventive)分銷商和使用者對(duì)所采取措施的建議Advice on actions to be taken by the distributor and the user.附加資料Attached please find 英文版市場(chǎng)安全公告Field Safety Notice (FSN) in English 國(guó)語(yǔ)版市場(chǎng)安全公告FSN in national language 其它（請(qǐng)?jiān)斒觯㎡thers (please specify) 在EEA和瑞士?jī)?nèi)受市場(chǎng)安全糾正措施影響的國(guó)家： These countries within the EEA and Switzerland are affected by this FSCA:- 在EEA和瑞士?jī)?nèi) - within the EEA and Switze