BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1960198 · Received December 21, 2010

    Report

    Report Number
    3002158293-2010-01348
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    September 16, 2010
    Report Date
    December 16, 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 (B)(4) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (BATTERY NOT HOLDING A CHARGE) HAS BEEN CONFIRMED. A ROOT CAUSE ANALYSIS IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF EVALUATION. 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) MALE PATIENT'S DOWNLOAD REVEALED SEVERAL BATTERY FAULTS. CUSTOMER SUPPORT CONTACTED THE PATIENT'S MOTHER AND ISSUED A REPLACEMENT BATTERY PACK.

    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 17 YR