BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5535552 · Received March 30, 2016

    Report

    Report Number
    3008642652-2016-01920
    Event Type
    Malfunction
    Date Received
    March 30, 2016
    Date of Event
    March 21, 2016
    Report Date
    March 28, 2016
    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 (NON-FUNCTIONAL TES) HAS BEEN CONFIRMED. AS RECEIVED, THE BELT FAILED INCOMING TESTING, SPECIFICALLY THE TE RECOGNITION TEST. UPON INVESTIGATION THE ELECTRODE BELT FAILED A THERAPY ELECTRODE RECOGNITION TEST. THE CAUSE FOR THE FAILURE WAS ISOLATED TO AN OPEN PULSE WIRE IN THE CABLE CONNECTING ECG "A" AND ECG "B" TO THE FRONT THERAPY ELECTRODE AND AN OPEN IN THE CABLE CONNECTING ECG "B" TO THE DISTRIBUTION NODE (DN). THE ROOT CAUSE OF THE OPEN PULSE WIRE IS EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT.

    Description of Event or Problem · 1

    A US DISTRIBUTOR RETURNED ELECTRODE BELT SN (B)(4) AND REPORTED THAT THE THERAPY ELECTRODES WERE NON-FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191901 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1