BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2221467 · Received August 17, 2011

    Report

    Report Number
    3008642652-2011-00458
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 2, 2011
    Report Date
    August 15, 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 CHARGER SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER PROBLEM) WAS CONFIRMED. UPON EVAL, IT WAS DETERMINED THAT THE POWER UNIT CONNECTOR WOULD NOT POWER UP THE CHARGER. THE ROOT CAUSE FOR THE FAULTY CONNECTION IS LIKELY DUE TO THE PINS IN THE CONNECTOR BEING RECESSED DUE TO A COMBINATION OF AN ASSEMBLY ERROR AND EXCESSIVE FORCE APPLIED DURING MATING. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CONNECTOR. THE PT RECEIVED A REPLACEMENT CHARGER.

    Description of Event or Problem · 1

    A ZOLL PT SERVICE REP (PSR) CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT, PRIOR TO FITTING A (B)(6) FEMALE WITH THE DEVICE, THE MODEM/CHARGER WOULD NOT TURN ON. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER.

    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 46 YR