BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2232946 · Received July 22, 2011

    Report

    Report Number
    3008642652-2011-00282
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 19, 2011
    Report Date
    July 22, 2011
    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 OUTPUT VOLTAGE WAS MEASURED AT 2.84V. THE CAUSE FOR THE LOW OUTPUT VOLTAGE CANNOT BE POSITIVELY DETERMINED. A ROOT CAUSE ANALYSIS IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF ROOT CAUSE ANALYSIS. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PATIENT RECEIVED A REPLACEMENT BATTERY PACK. NO PROBLEMS WERE DISCOVERED WITH THE PATIENT'S SECOND BATTERY PACK.

    Description of Event or Problem · 1

    THE WIFE OF A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S BATTERIES WILL NOT CHARGE. THE PATIENT WAS ISSUED 2 REPLACEMENT BATTERY PACKS.

    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 77 YR