BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1951285 · Received December 14, 2010

    Report

    Report Number
    3002158293-2010-01306
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 19, 2010
    Report Date
    December 6, 2010
    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 SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE BATTERY CHARGER WAS NOT FUNCTIONAL AND WOULD NOT CHARGE THE PT'S BATTERY PACKS. UPON EVALUATION, THE POWER BRICK WAS FOUND TO BE DEFECTIVE. THE ROOT CAUSE OF THE DEFECTIVE POWER BRICK CANNOT BE POSITIVELY DETERMINED. ONCE THE POWER BRICK WAS REPLACED, THE CHARGER WAS FULLY FUNCTIONAL. NO ADVERSE EVENT RESULTED FROM THE INTERMITTENT BATTERY CHARGER. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    A PT SERVICE REPRESENTATIVE ASSISTING A (B)(6) FEMALE PT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT SERVICE TO REPORT AN ISSUE WITH A CHARGER. SHE REPORTS THE CHARGER WOULD NOT POWER ON, DESPITE PLUGGING IT INTO MULTIPLE OUTLETS. THE PT WAS PROVIDED WITH 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 29 YR