BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 8744800 · Received June 28, 2019

    Report

    Report Number
    3008642652-2019-05085
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    May 26, 2019
    Report Date
    June 26, 2019
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED CABLE) HAS BEEN CONFIRMED. UPON INVESTIGATION, BELT WAS UNABLE TO COMPLETE ESSENTIAL PERFORMANCE TESTING. THE ROOT CAUSE FOR THE FAILURE WAS THE CABLE CONNECTING THE DISTRIBUTION NODE (DN) TO THE REAR THERAPY ELECTRODES WAS PULLED OUT OF THE STRAIN RELIEF, DAMAGING THE GEL FIRE WIRES IN THE CABLE AND BREAKING THE SOLDER JOINT CONNECTING THE REAR PULSE WIRES ON THE DN. THE ROOT CAUSE FOR THE STRAINED CABLE WAS EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT'S ELECTRODE BELT WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536689 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005012

    Patients

    Seq Age Sex Outcome Treatment
    1