BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1027123 · Received April 9, 2008

    Report

    Report Number
    3002158293-2008-00144
    Event Type
    Malfunction
    Date Received
    April 9, 2008
    Date of Event
    January 16, 2008
    Report Date
    April 4, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATES: BATTERY PACK - 10/2007. BATTERY PACK - 10/2007. DEVICE EVAL SUMMARY: DEVICE EVALS OF BATTERY CHARGER, BOTH BATTERY PACKS HAVE BEEN COMPLETED. THE PROBLEM WAS CONFIRMED. THE CAUSE OF THE FAULT FLAGS WAS CORRODED BATTERY CONTACT TERMINALS IN THE BATTERY CONNECTOR OF THE CHARGER. THE CORROSION PREVENTED PROPER CONTACT WITH THE BATTERY PACK CONNECTOR CONTACTS. THE ROOT CAUSE OF THE CORRODED TERMINALS WAS PROBABLY LIQUID SPILLAGE INTO THE BATTERY WELL AREA OF THE CHARGER. BOTH BATTERY PACKS PASSED ALL FUNCTIONAL TESTS. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CHARGER. THE PT RECEIVED REPLACEMENT BATTERY PACKS AND CHARGER.

    Description of Event or Problem · 1

    A RECENT DOWNLOAD FROM A FEMALE PT REVEALED SEVERAL "BATTERY PACK FAULT" AND "BATTERY CHARGER FAULT" FLAGS. LIFECOR CUSTOMER SUPPORT CONTACTED THE PT TO REPLACE BOTH BATTERY PACKS AND THE BATTERY CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR