BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2102011 · Received May 20, 2011

    Report

    Report Number
    3002158293-2011-00571
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 17, 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 SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY WON'T HOLD CHARGE) HAS BEEN CONFIRMED. UPON EVAL, THE BATTERY WAS FOUND TO HAVE A FULL CHARGE CAPACITY BELOW SPECIFICATIONS. THE CAUSE FOR THE LOW FULL CHARGE CAPACITY CANNOT BE POSITIVELY DETERMINED BUT WAS LIKELY A RESULT OF DEFECTIVE CELLS. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A (B)(6) OLD FEMALE PT'S HUSBAND CONTACTED THE PT'S TERRITORY MANAGER TO REPORT THAT ONE OF THE PT'S BATTERIES WILL NOT HOLD A CHARGE. ZOLL CUSTOMER SUPPORT THEN CONTACTED THE PT'S HUSBAND AFTER A REVIEW OF THE DOWNLOAD SHOWING NO BATTERY FAULTS. THE PT WAS ISSUED 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 54 YR