BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4210362 · Received August 8, 2014

    Report

    Report Number
    3008642652-2014-02405
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 16, 2014
    Report Date
    August 8, 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) IS COMPLETE. THE REPORTED PROBLEM (UNABLE TO PERFORM DETECT AND TREAT) WAS CONFIRMED. AS RECEIVED, THE ELECTRODE BELT FAILED INCOMING TESTING. UPON INVESTIGATION, THE CABLE CONNECTING THE DISTRIBUTION NODE (DN) TO REAR THERAPY PAD (TE) WAS PULLED FROM THE STRAIN RELIEF. THE CAUSE OF THE TEST FAILURE WAS THE PULLED DN TO REAR TE CABLE. THE ROOT CAUSE OF THE PULLED DN TO REAR TE CABLE CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY DUE TO EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED BELT.

    Description of Event or Problem · 1

    A UNITED STATES DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT ELECTRODE BELT SN (B)(4) WAS UNABLE TO PERFORM THE DETECT AND TREAT TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468828 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA