BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2140302 · Received June 15, 2011

    Report

    Report Number
    3008642652-2011-00049
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    April 4, 2011
    Report Date
    June 14, 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 MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WON'T POWER UP) HAS BEEN CONFIRMED. UPON EVALUATION, THERE WAS EVIDENCE THAT THE MONITOR EXPERIENCED A FAILURE WHICH DAMAGED MULTIPLE COMPONENTS ON THE COMPUTER/ANALOG BOARD AND THE DEFIBRILLATOR BOARD. THE CAUSE OF THE FAILURE CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED COMPONENTS. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT NEITHER OF HER BATTERIES WOULD POWER UP HER MONITOR. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    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 25 YR