BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4802500 · Received May 26, 2015

    Report

    Report Number
    3008642652-2015-03333
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Date of Event
    May 9, 2015
    Report Date
    May 18, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (NON-FUNCTIONAL) TE'S HAS BEEN CONFIRMED. 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 THE FRONT THERAPY ELECTRODE. THERE WAS NO SIGN OF EXTERNAL DAMAGE TO THE CABLE. THE ROOT CAUSE FOR HE OPEN WIRE WAS EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FORM THE OPEN PULSE WIRE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341188 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA