【正文】 tion ReportMedical Devices Vigilance System(MEDDEV )1. Administrative informationTo which NCA(s) is this report being sent?Type of report□Initial report□Follow up report□Final reportDate of this reportReference number assigned by the manufacturerFSCA reference number assigned by NCAIncidence reference number assigned by NCAName of the coordinating national petent authority (if applicable)2. Information on submitter of the reportStatus of submitter□Manufacturer□Authorised representative within EEA, Switzerland and Turkey□Others (identify the role):3 Manufacturer informationNameContact nameAddress PostcodeCityPhoneFaxEmailCountry4 Authorised representative informationNameContact nameAddressPostcodeCityPhoneFaxEmailCountry5 National contact point informationNational contact point nameName of the contact personAddressPostal codeCityPhoneFaxEmailCountry6 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 numberCatalogue numberSerial number(s)lot/batch number(s)Device Manufacturing dateExpiry dateSoftware version number (if applicable)Accessories/associated device (if applicable)Notified body (NB) ID number7 Description of FSCABackground information and reason for the FSCADescription and justification of the action (corrective/preventive)Advice on actions to be taken by the distributor and the userProgress of FSCA , together with reconciliation data (Mandatory for a Final FSCA)Attached please find□Field Safety Notice (FSN) in English□FSN in national language□Others (please specify):FSN Status□Draft□FinalTime schedule for the implementation of the different actionsThese 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:8 CommentsI affirm that the information given above is correct to the best of my knowledge.………………………………………………………SignatureName City DateSubmission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorizedrepresentative or the national petent authority that the content of this report is plete or accurate, that themedical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to thealleged death or deterioration in the state of the health of any person.附錄五：Urgent Field Safety NoticeCommercial name of the affected product,FSCAidentifier (. date)Type of action (. chapter 4 definition of a FSCA).Date:Attention: ///////////////Details on affected devices:Specific details to enable the affected product to be easily identified . type of device ,model name and number, batch/ serial numbers of affected devices and part or ordernumber.Insert or attach list of individual devices.(Possible reference to a manufacturer web site.)Description of the problem:A factual statement explaining the reasons for the FSCA, including description of the devicedeficiency or malfunction, clarification of the potential hazard associated with the continueduse of the device and the associated risk to the patient, user or other person.Any possible risk to patients associated with previous use of affected devices.Advise on action to be taken by the user:Include ,as appropriate:IRLDublin 2353/1/6714711353/1/671192ICELANDMinistry of Health Haw gavegur 116 IS15035/45/60970035/45/51965and Social ServiceTeykjiavikITALY DottissaMinstry of Health lndustria 20。DirCEtion1 Place Fontenoy33/1/40/56443633/1/405649des Hopitaux(site materiovigilance:)F75370 Paris 07SPGERMANYBundesinstitut fur Arzneimittel undSeestr,1011 D13353 Berlin49/30/4548538449/30/75530Herrn StoBleinMedizinprodukle。 ，及時(shí)向歐盟授權(quán)代表通知地址和電話等聯(lián)絡(luò)的變更情況。 ； ，其文檔的保存期限按照MDD規(guī)定，從最后一批產(chǎn)品制造日期開(kāi)始，應(yīng)至少5年； （顧客投訴和歐盟法律、法規(guī)的變更信息）及時(shí)傳遞回公司； ，應(yīng)及時(shí)通知公司，并協(xié)助公司處理醫(yī)療器械事故，負(fù)責(zé)向歐盟所在國(guó)家的主管機(jī)構(gòu)報(bào)告《制造商事故報(bào)告》、《市場(chǎng)安全通告》、《市場(chǎng)安全糾正措施》、《最終質(zhì)量事故調(diào)查報(bào)告》、《制造商的趨勢(shì)報(bào)告》、《國(guó)家主管當(dāng)局報(bào)告》等，傳遞歐盟所在國(guó)家的主管機(jī)構(gòu)反饋信息。 ，是為保證公司的文件資料與歐盟授權(quán)代表能夠及時(shí)、有效地傳遞，必須時(shí)刻關(guān)注其地址、電話等是否變更。 《最終質(zhì)量事故調(diào)查報(bào)告》，并填寫《制造商的趨勢(shì)報(bào)告》，按照本公司提出的《市場(chǎng)安全糾正措施》采取必要的糾正和預(yù)防措施，通過(guò)與主管當(dāng)局的商討，決定進(jìn)行產(chǎn)品召回等措施； 《最終質(zhì)量事故調(diào)查報(bào)告》和《國(guó)家主管當(dāng)局報(bào)告》，其內(nèi)容包括最終調(diào)查的結(jié)論和所采取的相應(yīng)措施，并由歐盟授權(quán)代表報(bào)告主管機(jī)構(gòu)；適用時(shí)，向認(rèn)證的公告機(jī)構(gòu)報(bào)告。 ，在警戒系統(tǒng)下應(yīng)向歐盟授權(quán)代表以及其他機(jī)構(gòu)代表通告質(zhì)量事故，同時(shí)也應(yīng)通知認(rèn)證的公告機(jī)構(gòu)。這些狀況或早已存在或發(fā)生在器械使用過(guò)程中或本公司的產(chǎn)品業(yè)已證明達(dá)到了預(yù)期用途； ； ，本公司的產(chǎn)品保護(hù)性措施正常運(yùn)行且有效； ； 。 d）當(dāng)不能確定其可報(bào)告性時(shí)，應(yīng)在上述相應(yīng)的時(shí)限內(nèi)提交一份《制造商事故報(bào)告》。 以上資料必須于《制造商事故報(bào)告》一起上報(bào)有關(guān)主管當(dāng)局。嚴(yán)重?fù)p害健康的情形可能包括：