BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 8861120 · Received August 5, 2019

    Report

    Report Number
    3008642652-2019-05701
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Date of Event
    June 8, 2019
    Report Date
    July 23, 2019
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    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 MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED MONITOR CASE) HAS BEEN CONFIRMED. UPON INVESTIGATION THE MONITOR WAS UNABLE TO COMMUNICATE WITH AN ELECTRODE BELT. THE MONITOR'S ELECTRODE BELT CONNECTOR WAS BROKEN FREE FROM THE MONITOR ENCLOSURE, DAMAGING WIRES WITHIN THE CONNECTOR. ADDITIONALLY, CONTAMINATION WAS FOUND ON THE DEFIBRILLATION BOARD. THE ROOT CAUSE FOR THE DAMAGED CONNECTOR WAS EXCESSIVE FORCE. THE ROOT CAUSE FOR THE CONTAMINATION WAS INGRESS OF AN UNKNOWN LIQUID. LIFEVEST PATIENT TRAINING MATERIALS HAVE BEEN UPDATED AS A REMINDER NOT TO EXPOSE THE LIFEVEST ELECTRONIC COMPONENTS TO LIQUIDS. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR.

    Description of Event or Problem · 1

    A US DISTRIBUTOR RETURNED A PATIENT'S MONITOR AND REPORTED THAT THE MONITOR HAD A DAMAGED CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656459 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1