BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1053462 · Received May 28, 2008

    Report

    Report Number
    3002158293-2008-00223
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 27, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF BATTERY PACK HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE CAUSE OF THE BATTERY PACK NOT CHARGING WAS DEFECTIVE BATTERY CELLS WITHIN THE BATTERY PACK. THE ROOT CAUSE OF THE DEFECTIVE CELLS IS NOT KNOWN, BUT IS PROBABLY RANDOM COMPONENT FAILURE. THE DEFECTIVE CELLS WERE REPLACED. THE BATTERY PACK WAS RETESTED AND RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE FAULTY BATTERY PACK. THE PT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT ONE OF HIS BATTERY PACKS WILL NOT FULLY CHARGE. HE STATED THAT HE PLACED IT ON THE CHARGER AND THE GREEN LIGHT WOULD ILLUMINATE. HE STATED THAT HE THEN PLACED THIS BATTERY PACK INTO THE MONITOR AND THE MONITOR SHOWED THAT THE BATTERY PACK WAS ONLY HALF FULL. SUPPORT SENT THE PT A REPLACEMENT BATTERY PACK.

    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 73 YR