BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1913009 · Received November 18, 2010

    Report

    Report Number
    3002158293-2010-01212
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    September 23, 2010
    Report Date
    November 12, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY/CHARGER FAULTS) HAS BEEN CONFIRMED. UPON EVALUATION, THE BATTERY WAS FOUND TO HAVE DEFECTIVE CELLS. ONE OR MORE OF THE CELLS HAD RESIDUE/CORROSION ON THEM. THE SOURCE OF THE RESIDUE/CORROSION HAS NOT BEEN POSITIVELY IDENTIFIED BUT IS LIKELY ELECTROLYTE FROM A LEAKING CELL. THE ROOT CAUSE OF THE LEAKING CELL WAS NOT POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PT REC'D A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A PT SERVICE REP (PSR) CALLED WHILE WITH A (B)(6) FEMALE PT TO REPORT THAT ONE OF THE PT'S BATTERIES WAS CAUSING A BATTERY FAULT WHEN PLACED ON THE CHARGER. THE PT WAS SENT 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 30 YR