BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2232965 · Received July 22, 2011

    Report

    Report Number
    3008642652-2011-00280
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 18, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    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 SN (B)(4) IS ONGOING. THE REPORTED PROBLEM ("CHARGER HAS A PROBLEM" MESSAGE) HAS BEEN CONFIRMED. UPON INITIAL INSPECTION, THE CHARGER/MODEM WOULD NOT START THE BATTERY CAPACITY TEST, THE CHARGER/MODEM SHOWED A FAULT ON THE SCREEN, AND THE CHARGER/MODEM FULLY DRAINED THE TEST BATTERY. THE ROOT CAUSE OF THE DEFECTIVE CHARGER/MODEM IS STILL UNDER INVESTIGATION. WILL FOLLOW UP WITH A SUPPLEMENTAL REPORT ONCE ROOT CAUSE HAS BEEN IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CHARGER/MODEM. THE PATIENT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    AN (B)(6) FEMALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER CHARGER/MODEM WAS DISPLAYING A "CHARGER HAS A PROBLEM" MESSAGE. THE PATIENT WAS ISSUED A REPLACEMENT CHARGER/MODEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR