BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6681425 · Received June 30, 2017

    Report

    Report Number
    3008642652-2017-05504
    Event Type
    Malfunction
    Date Received
    June 30, 2017
    Date of Event
    June 2, 2017
    Report Date
    June 22, 2017
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005012
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST BELT MESSAGES, CHECK TE MESSAGES) WAS CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED A THERAPY ELECTRODE RECOGNITION TEST. THE CAUSE FOR THE FAILURE AND REPORTED MESSAGES WAS ISOLATED TO THE ELECTRODE BELT DISTRIBUTION NODE (DN). THE JOINT CONNECTING THE REAR PULSE WIRES WAS OPEN INSIDE THE DN. THE ROOT CAUSE FOR THE OPEN JOINT COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT.

    Description of Event or Problem · 1

    A US DISTRIBUTOR RETURNED A PATIENT'S ELECTRODE BELT AND REPORTED THAT THE PATIENT WAS RECEIVING "CHECK THERAPY ELECTRODE" MESSAGES AND "ADJUST BELT" MESSAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460718 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005012

    Patients

    Seq Age Sex Outcome Treatment
    1