警戒-警戒系统趋势报告rev7.doc

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1、ReportFormManufacturersTrendReportMedicalDevicesVigilanceSystem(MEDDEV2.12/1rev7)v.12/111.AdministrationInformationRecipient(NameofNationalCompetentAuthorityNCA)AddressofNationalCompetentAuthorityDateofthisreportReferencenumberassignedbythemanufacturerRefereneenumberassignedbyNCATypeo

2、freport□TrendInitial□TrendFollowup□TrendFinalDotheseincidents/trendrepresentaseriouspublichealththreat?□Yes□NoIdentifytowhatotherNCAsthisreportwasalsosent2.InformationonsubmitterofthereportStatusofsubmitter□Manufacturer□AuthorisedRepresentativewithinEEA,SwitzerlandandTurkey□Others:(id

3、entifytherole):3.ManufacturerinformationNameContactnameAddressPostcodeCityPhoneFaxE-mailCountry4.AuthorisedRepresentativeinformationNameContactnameAddressPostcodeCityPhoneFaxE-mailCountry5.Submittefsinformation(ifdifferentfromsection3or4)Submitter'snameContactnameAddressPostcodeCityPh

4、oneFaxE-mailCountry6.MedicalDeviceInformationClass□AIMDActiveImplants□MDDClassIII□MDDClasslib□MDDClassIla□MDDClass1□IVDAnnexIIListA□IVDAnnexIIListB□IVDDevicesforself-testing□IVDGeneralNomenclaturesystem(preferableGMDN)NomenclaturecodeNomenclaturetextCommercialname/brandname/makeModeln

5、umber(s)orFamilynameCataloguenumber(s)Serialnumberrange(ifapplicable)Lot/batchnumberrange(ifapplicable)Softwareversionnumber(ifapplicable)Accessories/associateddevices(ifapplicable)NotifiedBody(NB)ID一Number7.InformationonTrendReportDatethetrendwasidentifiedDescriptionnarrativeforident

6、ifiedtrendTimeperiodoftrendanalysisEstablishedtriggerlevelHaveanyofthetrendedeventsbeensubmittedindividuallyasreportableeventsundervigilanee?□Yes□NoIfyes,pleaselisthowmanyandtowhichCompetentAuthority&Manufacturer^preliminarycommentsManufacturerspreliminaryanalysisintocausesoftrendInit

7、ialcorrectiveactions/preventiveactionsimplementedbythemanufacturerExpecteddateofnextreport9.ResultsofmanufacturersfinalinvestigationintotrendThemanufacturerstrendanalysisresultsRemedialaction/correctiveaction/preventiveaction/FieldSafetyCorrectiveActionTimescheduledfortheimplementatio

8、nofth