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附件3制造商向国家主管当局提交报告格式表ANNEX3REPORTFORMFORMANUFACTURER’STOTHENATIONALCOMPETENTAUTHORITYManufacturer’sIncidentReport制造商事故报告医疗器械警戒系统（MEDDEV2.12/1rev8）1行政信息Administrativeinformation接收者Recipient国家主管当局名称NameofNationalCompetentAuthority(NCA)国家主管当局地址AddressofNationalcompetentAuthority主管当局盖章StampboxfortheCompetentAuthority(～60×40mm)该报告的时间Dateofthisreport制造商指定的参考号码Referencenumberassignedbythemanufacturer国家主管当局指定的接收者索引号码ReferencenumberassignedbyNCA报告类型Typeofreport□初始报告Initialreport□跟踪报告Follow-upreport□包含初始和最终的联合报告CombinedInitialandfinalreport□最终报告Finalreport事件是否构成严重危害公众健康Doestheincidentrepresentaseriouspublichealththreat?□是Yes□否NoClassificationofincident事故类型□死亡death□健康状况的严重损坏，严重公共健康威胁unanticipatedseriousdeteriorationinstateofhealth□其他所有可报告事故ALLotherreportableincidents确定该报告的其他发送国家主管当局IdentifytowhatotherNCAsthisreportwasalsosent2报告提交人信息Informationonsubmitterofthereport发送人身份Statusofsubmitter□制造商Manufacturer□EEA和瑞士内授权代表AuthorisedRepresentativewithinEEAandSwitzerland□其他（请表明其身份）Others:(identifytherole)3制造商信息Manufacturerinformation名称Name制造商联系人Contactname地址Address邮政编码Postalcode城市City电话Phone传真Fax电子邮件E-mail国家Country4授权代表信息AuthorizedRepresentativeinformation授权代表名称NameoftheAuthorizedRepresentative授权代表联系人TheAuthorizedRepresentative’scontactperson地址Address邮政编码Postalcode城市City电话Phone传真Fax电子邮件E-mail国家Country2)5报告提交者信息（如果不同于第3、4节）Submitter’sinformation(ifdifferentfromsection3or4)提交者姓名submitter’sname联系人姓名Nameofthecontactperson地址Address邮政编码Postalcode城市City电话Phone传真Fax电子邮件E-mail国家Country2)6医疗器械信息Medicaldeviceinformation分类Class□有源植入类AIMDActiveimplants□MDD法规规定第Ш类MDDClassШ□IVD附件Ⅱ列表AIVDAnnexⅡListA□MDD法规规定第Ⅱ类MDDClassⅡb□IVD附件Ⅱ列表BIVDAnnexⅡListB□MDD分类ⅡaMDDClassⅡa□IVD自测诊断器械IVDDevicesforself-testing□MDD分类MDDClassⅠ□IVD一般IVDGeneral分类系统(最好是GMDN)Nomenclaturesystem(preferableGMDN)分类系统代号Nomenclaturecode分类内容Nomenclaturetext商品名/品牌名/制造者Commercialname/brandname/make型号Modeand/or编号cataloguenumber序列(适用时)号Serialnumber(s)（ifapplicable）批号lot/batchnumber(s)软件版本号(适用时)Softwareversionnumber(ifapplicable)制造日期DeviceManufacturingdate,失效期Expirydate附件/随附器械(适用时)Accessories/associateddevice(ifapplicable)公告机构识别号码NotifiedBody(NB)ID-number7事故信息Incidentinformation使用点报告参考号码,适用时Userfacilityreportreferencenumber,ifapplicable制造商知悉日期Manufacturersawarenessdate事故发生日期Datetheincidentoccurred事故描述Incidentdescriptionnarrative涉及病人数量(若知)Numberofpatientsinvolved(ifknown)涉及器械数量(若知)Numberofmedicaldevicesinvolved(ifknown)医疗器械现处地点(若知)Medicaldevicecurrentlocation/disposition(ifknown)事故发生时医疗器械的使用者Operatorofthemedicaldeviceatthetimeofincident(selectone)□健康护理专家healthcareprofessional□病人patient□其他other医疗器械的使用者(请选择)Usageofthemedicaldevice(selectfromlistbelow)□初次使用initialuse□一次性器械的重复使用reuseofasingleusemedicaldevice□可重复使用器械的再次使用reuseofareusablemedicaldevice□修复后使用/维修re-serviced/refurbished□其他(请详述)other(pleasespecify)□使用前注意到问题problemnotedprioruse8病人信息Patientinformation事故发生后病人状况patientoutcome有关的健康护理点采取的补救措施Remedialactiontakenbythehealthcarefacilityrelevanttothecareofthepatient事故发生时病人的年龄,适用时Ageofthepatientatthetimeofincident,ifapplicable性别,适用时Gender,ifapplicable□女性Female□男性Male重量,适用时Weightinkilograms,ifapplicable9健康护理点信息Healthcarefacilityinformation健康护理点名称Nameofthehealthcarefacility护理点内联系人Contactpersonwithinthefacility地址Address邮政编码Postalcode城市City电话Phone传真Fax电子邮件E-mail国家Country2)10制造商初始意见(初次/跟踪报告)Manufacturer’spreliminarycomments(Initial/Follow-upreport)制造商初始分析Manufacturer’spreliminaryanalysis制造商采取的初始纠正预防措施Initialcorrectiveactions/preventiveactionsimplementedbythemanufacturer下次预计报告日期Expecteddateofnextreport11制造商末次调查结果(末次报告)Resultsofmanufacturersfinalinvestigation(Finalreport)制造商器械分析结果Resultsofmanufacturersfinalinvestigation(Finalreport)制造商器械分析结果Themanufacturer’sdeviceanalysisresults补救措施/纠正措施/预防措施/市场安全纠正措施Remedialaction/correctiveaction/preventiveaction/FieldsafetyCorrectiveAction注意：NOTE:提交这个市场安全纠正措施需要填附表4InthecaseofaFSCAthesubmitterneedstofillintheformofAnnex4确定采取的措施时间表Timeschedulefortheimplementationoftheidentifiedactions制造商末次评估报告Finalcommentsfromthemanufacturer进一步调查Furtherinvestigations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?Isthemanufacturerawareofsimilarincidentswiththistypeofmedicaldevicewithasimilarrootcause?□是Yes□否No类似事件的数量Numberofsimilarincidents如果是,请表明在何国家和事故报告索引号.Ifyes,stareinwhichcountriesandthereportreferencenumbersoftheincidents.仅对末次报告适用:医疗器械被分布到下列国家内:ForFinalReportonly:Themedicaldevicehasbeendistributedtothefollowingcountries:-在EEA和瑞士内:-WithintheEEAandSwitzerland:□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-CandidateCountries□CR□TR□所有EEA-,候补国家和瑞士□ALLEEA-,CandidateCountriesandSwitzerland-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。Iaffirmthattheinformationgivenaboveiscorrecttothebestofmyknowledge.签名Signature姓名Name：城市City:日期Date:Submissionofthisreportdoesnot,initself,representaconclusionbythemanufacturerand/orauthorizedrepresentativeortheNationalCompetentAuthoritythatthecontentofthisreportiscompleteoraccurate,thatthemedicaldevice(S)causedorcontributedtotheallegeddeathordeteriorationthestateofthehealthofanyperson.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