BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2031502 · Received March 21, 2011

    Report

    Report Number
    3002158293-2011-00336
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 12, 2011
    Report Date
    March 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 EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACK (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY/CHARGER FAULT) HAS BEEN CONFIRMED. UPON EVALUATION, THE WHITE WIRE WAS DETACHED FROM THE BATTERY CELL. THE CAUSE FOR THE DETACHED WIRE CANNOT BE POSITIVELY DETERMINED BUT WAS LIKELY CAUSED BY A SEVERE SHOCK FROM DROPPING THE PACK. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PATIENT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A REVIEW OF A (B)(6) FEMALE PATIENT'S DOWNLOAD REVEALED SEVERAL BATTERY FAULTS. ZOLL CUSTOMER SUPPORT CONTACTED THE PATIENT AND 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 73 YR