BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4093067 · Received September 10, 2014

    Report

    Report Number
    3008642652-2014-02776
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    August 15, 2014
    Report Date
    September 5, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (UNABLE TO COMMUNICATE WITH MONITOR) HAS BEEN CONFIRMED. AS RECEIVED, THE BELT FAILED INCOMING TESTING. UPON EVALUATION, THERE WAS AN OPENING ALONG THE FRONT PULSE WIRE AND THE BROWN (-5V) WIRE OF THE TRUNK CABLE. THE CAUSE OF THE TEST FAILURE IS THE OPEN WIRES. THE ROOT CAUSE OF THE OPEN WIRES CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE PLACED ON THE CABLE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BELT.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT ELECTRODE BELT SN (B)(4) WAS UNABLE TO COMMUNICATE WITH A MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559851 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA