BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2233006 · Received July 20, 2011

    Report

    Report Number
    3008642652-2011-00253
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    May 27, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ZOLL LIFECOR CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF CHARGER/MODEM (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER/MODEM WILL NOT WORK) HAS BEEN CONFIRMED. UPON INSPECTION THE CHARGER/MODEM WOULD NOT POWER UP. THE CHARGER/MODEM PASSED A FLASH TEST BUT FAILED DURING FLASH REPROGRAMMING. THE ROOT CAUSE OF THE DEFECTIVE CHARGER/MODEM CANNOT BE POSITIVELY IDENTIFIED, BUT IS LIKELY DUD TO CORRUPT PROGRAMMING. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CHARGER/MODEM. THE PT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    A ZOLL PT SERVICE REPRESENTATIVE (PSR) CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT WHILE GETTING READY FOR A PT FITTING SHE NOTICED THE BATTERY CHARGER/MODEM WAS NOT WORKING. THE PT WAS NEVER GIVEN THE DEFECTIVE BATTERY CHARGER/MODEM. THE PSR WAS ISSUED A REPLACEMENT CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DIEFIBRILLATOR MVK ZOLL LIFECOR CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA