BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6210841 · Received December 28, 2016

    Report

    Report Number
    3008642652-2016-09262
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Date of Event
    November 6, 2016
    Report Date
    December 14, 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 (ARRHYTHMIA ALARMS, ADJUST BELT MESSAGES) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED AN ECG FALL-OFF TEST. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A SHORT IN ECG "C". AN UNUSED PULSE WIRE MIGRATED WITHIN THE ECG ELECTRODE AND PIERCED THE BROWN (LEAD 1-) AND ORANGE (LEAD 2-) WIRES. THE ROOT CAUSE FOR THE MIGRATED WIRE WAS UNABLE TO BE POSITIVELY IDENTIFIED. 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 THE ELECTRODE BELT WAS CAUSING ARRHYTHMIA ALARMS AND ADJUST BELT MESSAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861613 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1