BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACHILLON SYSTEM

    MDR report key: 6181306 · Received December 16, 2016

    Report

    Report Number
    9615741-2016-00068
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Report Date
    December 1, 2016
    Manufacturer
    NEWDEAL SAS
    Product Code
    HCF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON FEBRUARY 3, 2017. THE INVESTIGATION INCLUDED: METHODS: REVIEW OF DEVICE HISTORY RECORDS; REVIEW OF COMPLAINTS HISTORY. RESULTS: DHR REVIEW; THE ISSUE IS A DISTRIBUTION-RELATED ISSUE. IT IS NOT RELATED TO THE PERFORMANCE OF THE PRODUCT. MOREOVER, NO LOT NUMBER HAS BEEN REPORTED (ITEM 119700SND), THUS A DHR REVIEW BY THE MANUFACTURING SITE IS NOT POSSIBLE. COMPLAINTS HISTORY; APPROX 0 COMPLAINT OF THE SAME NATURE HAS BEEN RECEIVED FOR THE PAST YEAR (0 COMPLAINTS / PRODUCT USES), INCLUDING THIS COMPLAINT. THIS IS NOT STATISTICALLY ADVERSE WHEN COMPARED TO THE COMPLAINT RATE FOR THE PRIOR TIME PERIOD (0 COMPLAINT / PRODUCT USES). CONCLUSION: THE INVESTIGATION HAS DEMONSTRATED THAT INTEGRA IS NOT RESPONSIBLE OF THE ISSUE REPORTED BY THE HOSPITAL. IT HAS BEEN OBSERVED THAT THE INTERNAL PROCESS "FIELD SAFETY CORRECTIVE ACTION (FIELD SAFETY NOTICE / RECALL)" HAS BEEN CORRECTLY FOLLOWED BY THE COMPLIANCE COORDINATOR BUT DATA PROVIDED TO INTEGRA BY THE SNITEM WAS NOT UP-TO-DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE SET WAS NOT CAPTURED IN THE JUNE, 2016 RECALL. THE SET WAS USED BY THE CUSTOMER. THE DEVICE SET WAS ON CONSIGNMENT IN THE HOSPITAL. WHEN THE HOSPITAL SENT A REQUEST TO RENEW THE DEVICE SET THAT HAD BEEN USED, THEY LEARNED THAT ON 23 JUNE 2016 ALL THE ACHILLON ON THE MARKET HAD BEEN RECALLED. THE PHARMACY OF THE HOSPITAL WAS NOT AWARE OF THIS RECALL SO THE CONSIGNMENT WAS NOT RETURNED TO INTEGRA. IT WAS REPORTED THE DEVICE WAS USED AS USUAL. IT WAS REPORTED THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832797 ACHILLON SYSTEM ACHILLON HCF NEWDEAL SAS

    Patients

    Seq Age Sex Outcome Treatment
    1