BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4973314 · Received August 5, 2015

    Report

    Report Number
    3008642652-2015-04575
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 20, 2015
    Report Date
    July 23, 2015
    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 SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DOES NOT COMMUNICATE WITH TEST MONITOR) WAS CONFIRMED. AS RECEIVED THERE WAS AN OPEN YELLOW (PGND) WIRE IN THE TRUNK CABLE. THE CAUSE OF THE FAULT IS THE OPEN WIRE. THE ROOT CAUSE OF THE OPEN WIRE IS EXCESSIVE FORCE PLACED ON THE CABLE. NO ADVERSE EVENT RESULTED FROM THE OPEN WIRE.

    Description of Event or Problem · 1

    A ZOLL DISTRIBUTOR ELECTRODE BELT SN (B)(4) INDICATING THAT IT WOULD NOT COMMUNICATE PROPERLY WITH A TEST MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515433 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1