BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5707252 · Received June 8, 2016

    Report

    Report Number
    3008642652-2016-03749
    Event Type
    Malfunction
    Date Received
    June 8, 2016
    Date of Event
    April 19, 2016
    Report Date
    June 6, 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 (ADJUST BELT, CHECK THERAPY ELECTRODE MESSAGES) 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 WIREIN THE REAR THERAPY ELECTRODE CABLE. THE PULSE WIRE SOLDER JOINT IN THE REAR 2-WIRE THERAPY ELECTRODE WAS BROKEN. THE ROOT CAUSE FOR THE BROKEN SOLDER JOINT COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE OPEN PULSE WIRE.

    Description of Event or Problem · 1

    A US DISTRIBUTOR RETURNED ELECTRODE BELT SN (B)(4) AND REPORTED THAT THE ELECTRODE BELT WAS CAUSING FREQUENT ADJUST BELT MESSAGES AND CHECK THERAPY ELECTRODE MESSAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360115 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1