BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6567702 · Received May 15, 2017

    Report

    Report Number
    3008642652-2017-04130
    Event Type
    Malfunction
    Date Received
    May 15, 2017
    Date of Event
    April 7, 2017
    Report Date
    May 15, 2017
    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 ("ADJUST BELT" AND "ADD GEL" MESSAGES) HAS BEEN CONFIRMED. UPON INVESTIGATION, THE ELECTRODE BELT FAILED A TE RECOGNITION TEST. THE REAR THERAPY ELECTRODE PULSE WIRE SOLDER JOINT IN THE DISTRIBUTION NODE (DN) WAS BROKEN. THE ROOT CAUSE FOR BROKEN SOLDER JOINT COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT.

    Description of Event or Problem · 1

    A US DISTRIBUTOR RETURNED AN ELECTRODE BELT AND REPORTED THAT IT WAS CAUSING EXCESSIVE "ADJUST BELT" MESSAGES AND "ADD GEL" MESSAGES IN THE ABSENCE OF A PRIOR GEL RELEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349408 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1