BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 4231018 · Received October 15, 2014

    Report

    Report Number
    3008642652-2014-03314
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 26, 2014
    Report Date
    October 14, 2014
    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 (BELT WILL NOT LATCH WITH TEST MONITOR) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT WAS UNABLE TO SECURELY CONNECT TO A MONITOR. THE ELECTRODE BELT'S TRUNK CONNECTOR AND LOCKING NUT WAS MISSING. THE ROOT CAUSE FOR THE MISSING TRUNK CONNECTOR AND LOCKING NUT COULD NOT BE POSITIVELY IDENTIFIED AND LOCKING NUT COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED BELT.

    Description of Event or Problem · 1

    US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT ELECTRODE BELT SN (B)(4) WOULD NOT SECURELY LATCH WITH THE TEST MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652815 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK MVK ZOLL MANUFACTURING CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA