BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6064231 · Received October 28, 2016

    Report

    Report Number
    3008642652-2016-07903
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    September 28, 2016
    Report Date
    October 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 SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHECK THERAPY PAD MESSAGES, ARRHYTHMIA ALARMS) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED A THERAPY ELECTRODE RECOGNITION TEST. THE CAUSE FOR THE FAILURE WAS AN OPEN PULSE WIRE IN THE CABLE CONNECTING ECG "A" AND ECG "B" TO THE FRONT THERAPY ELECTRODE, AND AN OPEN PULSE WIRE IN THE CABLE CONNECTING THE FRONT THERAPY ELECTRODE (TE) TO ECG "A". THE ROOT CAUSE FOR THE OPEN WIRE WAS 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 IT WAS RECEIVING "CHECK THERAPY PAD" MESSAGES AND ARRHYTHMIA ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714111 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1