BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3060698 · Received March 29, 2013

    Report

    Report Number
    3008642652-2013-00823
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 25, 2013
    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 SN (B)(4) IS STILL UNDERWAY. THE REPORTED PROBLEM (FAULT IN MONITOR) WAS CONFIRMED. AS RECEIVED, THE BATTERY WOULD NOT CHARGE OR POWER ON A MONITOR. 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 (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT ONE OF THE BATTERY PACKS WAS FAULTING IN THE MONITOR. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129586 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR