BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 4250206 · Received November 6, 2014

    Report

    Report Number
    3008642652-2014-03685
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 11, 2014
    Report Date
    November 4, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL 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 CABLE CONNECTOR LOCKING NUT WAS MISSING. THE ROOT CAUSE FOR THE MISSING LOCKING NUT COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY PHYSICAL ABUSE. ADDITIONALLY, THE ELECTRODE BELT TRUNK CABLE CONNECTOR HAD BENT PINS WHICH PREVENTED THE BELT FROM PROPERLY CONNECTING TO A MONITOR. THE ROOT CAUSE FOT THE BENT PINS COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE WHEN CONNECTING. NO ADVERSE EVENT RESULTED FROM THE DAMAGED BELT.

    Description of Event or Problem · 1

    A 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
    714300 LIFEVEST WCD 3000 SYSTEM MVK ZOLL MANUFACTURING CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA