【正文】 r StatePlease name:Date of PSRNew incidents this periodTotal number incidents via PSRTotal numberresolvedTotal number in progress 8. Manufacturer’s ments / investigation resultsInvestigation update for this periodInitial corrective actions / preventive actions implemented by the manufacturerRemended actions for this period, if anyExpected date of next PSR report9. DistributionThe medical device has been distributed to the following CountriesWithin EEA, Switzerland and Turkey:□AT □BE □BG □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 □TRCandidate Countries:□HR□All EEA, Candidate Countries, Switzerland and TurkeyOthers:10. CommentsSubmission of this report does not, in itself, represent a conclusion by the manufacturer and / orauthorized representative or the National Competent Authority that the content of this report isplete or accurate, that the medical device(s) listed failed in any manner and/or that the medicaldevice(s) caused or contributed to the alleged death or deterioration in the state of the health of anyperson.I affirm that the information given above is correct to the best of my knowledge.………………………………………………………Name City date附錄七：Manufacturer’s Trend ReportMedical Devices Vigilance System (MEDDEV )1. Administration InformationRecipient (Name of National Competent Authority NCA)Address of National Competent AuthorityDate of this reportReference number assigned by the manufacturerReference number assigned by NCAType of report□Trend Initial□Trend Follow up□Trend FinalDo these incidents / trend represent a serious public health threat?□Yes□NoIdentify to what other NCAs this report was also sent2. Information on submitter of the reportStatus of submitter□Manufacturer□Authorised Representative within EEA, Switzerland and Turkey□Others: (identify the role) :3. Manufacturer informationNameContact nameAddressPostcodeCityPhoneFaxEmailCountry4. Authorised Representative informationNameContact nameAddressPostcodeCityPhoneFaxEmailCountry5. Submitter’s information (if different from section 3 or 4)Submitter’s nameContact nameAddressPostcodeCityPhoneFaxEmailCountry6. Medical Device InformationClass□AIMD Active Implants□MDD Class III□MDD Class IIb□MDD Class IIa□MDD Class I□IVD Annex II List A□IVD Annex II List B□IVD Devices for selftesting□IVD GeneralNomenclature system (preferable GMDN)Nomenclature codeNomenclature textCommercial name/ brand name / makeModel number(s) or Family nameCatalogue number(s)Serial number range (if applicable)Lot/batch number range(if applicable)Software version number (if applicable)Accessories / associated devices (if applicable)Notified Body (NB) ID – Number7. Information on Trend ReportDate the trend was identifiedDescription narrative for identified trendTime period of trend analysisEstablished trigger levelHave any of the trended events been submitted individually as reportable events under vigilance?□Yes □NoIf yes, please list how many and to which Competent Authority8. Manufacturer’s preliminary mentsManufacturer’s preliminary analysis into causes of trendInitial corrective actions / preventive actions implemented by the manufacturerExpected date of next report9. Results of manufacturer’s final investigation into trendThe manufacturer’s trend analysis resultsRemedial action / corrective action / preventive action / Field Safety Corrective ActionTime scheduled for the implementation of the identified actionsFinal ments from the manufacturerFurther investigation10. The medical device has been distributed to the following Countrieshese countries within the EEA and Switzerland and Turkey are affected by this FSCAWithin EEA, Switzerland and Turkey:□AT □BE □BG □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 □TRCandidate Countries:□HR□All EEA, Candidate Countries, Switzerland and TurkeyOthers:11. CommentsSubmission of this report does not, in itself, represent a conclusion by the manufacturer and / orauthorized representative or the National Competent Authority that the content of this report is11. CommentsMEDDEV 2 121 rev. 8 Vigilance57plete or accurate, that the medical device(s) listed failed in any manner and/or that the medicaldevice(s) caused or contributed to the alleged death or deterioration in the state of the health of anyperson.I affirm that the information given above is correct to the best of my knowledge.………………………………………………………Name City date附錄八：NATIONAL COMPETENT AUTHORITY REPORTThis form should be used for the exchange of medical device informationbetween NCAR participants only. Completed forms should not be released tothe public.1. Is this report confidential? Yes [ ] No [ ]2. 程序文件 第 25 頁(yè) 共 25 頁(yè)