BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 9534834 · Received December 31, 2019

    Report

    Report Number
    3008642652-2019-10150
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Date of Event
    November 4, 2019
    Report Date
    December 17, 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 (ADD GEL MESSAGES, AND GEL LEAK) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT WAS DISPLAYING ADD GEL MESSAGES AND DEPLOYED GEL OUT OF THE REAR 1 THERAPY ELECTRODE. THE CAUSE FOR THE FAILURE WAS THE CABLE CONNECTING THE DISTRIBUTION NODE (DN) TO THE REAR THERAPY ELECTRODES WAS PULLED FROM THE STRAIN RELIEF, DAMAGING THE PULSE WIRE SOLDER CONNECTION IN THE DN AND DAMAGING GEL FIRE WIRES IN THE CABLE AND CAUSING THE REAR 1 THERAPY ELECTRODE TO DEPLOY GEL. 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 REPORTED THAT A PATIENT'S ELECTRODE BELT HAD A GEL LEAK AND WAS RECEIVING ADD GEL MESSAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331471 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005012

    Patients

    Seq Age Sex Outcome Treatment
    1