BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 7545756 · Received May 25, 2018

    Report

    Report Number
    3008642652-2018-04743
    Event Type
    Malfunction
    Date Received
    May 25, 2018
    Date of Event
    May 10, 2018
    Report Date
    May 24, 2018
    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 THAT THE (THERAPY ELECTRODES WERE NON-FUNCTIONAL) 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 WIRE IN THE CABLE CONNECTING ECG "A" AND ECB "B". THE ROOT CAUSE FOR THE OPEN WIRE WAS EXCESSIVE FORCE. BELT IS DESIGNED TO MEET THE MECHANICAL REQUIREMENTS OF IEC (B)(4). 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 THERAPY ELECTRODES WERE NON-FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388846 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005012

    Patients

    Seq Age Sex Outcome Treatment
    1