BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4955871 · Received July 31, 2015

    Report

    Report Number
    3008642652-2015-04697
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    July 27, 2015
    Report Date
    July 29, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CANNOT RUN DETECT AND TREAT) HAS BEEN CONFIRMED. UPON INVESTIGATION THE CABLE CONNECTING THE DISTRIBUTION NODE TO THE REAR THERAPY ELECTRODES WAS PULLED FROM THE STRAIN RELIEF, DAMAGING WIRES. THE ROOT CAUSE FOR THE STRAINED CABLE WAS EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE STRAINED CABLE.

    Description of Event or Problem · 1

    A US DISTRIBUTOR RETURNED ELECTRODE BELT SN (B)(4) AND REPORTED THAT THE ELECTRODE BELT FAILED FUNCTIONALITY TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501089 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1