BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2211993 · Received July 8, 2011

    Report

    Report Number
    3008642652-2011-00173
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 3, 2011
    Report Date
    July 8, 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 EVAL SUMMARY: DEVICE EVAL OF BATTERY PACK (B)(4) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (BATTERY/CHARGER FAULTS) HAS BEEN CONFIRMED. UPON EVAL THE BATTERY POWERED UP A TEST MONITOR, HOWEVER; BATTERY FAULTS WERE GENERATED WHEN THE BATTERY WAS CHARGED WITH A TEST CHARGER. A ROOT CAUSE ANALYSIS IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT AFTER COMPLETION OF THE ROOT CAUSE ANALYSIS. NO ADVERSE EVENT RESULTED FROM THE BATTERY/CHARGER FAULTS. THE PT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A PT SVC REP (PSR) CONTACTED ZOLL CUSTOMER SUPPORT WHILE ASSISTING A (B)(6) MALE PT TO REPORT THAT ONE OF THE PT'S BATTERY PACKS GENERATES A BATTERY FAULT WHEN PLACED ON THE CHARGER. THE PT WAS ISSUED A REPLACEMENT BATTERY PACK.

    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 71 YR