BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 13524398 · Received February 14, 2022

    Report

    Report Number
    3008642652-2022-01605
    Event Type
    Malfunction
    Date Received
    February 14, 2022
    Date of Event
    January 14, 2022
    Report Date
    August 16, 2022
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION OF MONITOR IS UNDERWAY. THE REPORTED PROBLEM (SERVICE CODE 102) HAS BEEN CONFIRMED. UPON INVESTIGATION THE MONITOR WAS DISPLAYING A SERVICE CODE 102 AND FAILED INCOMING FUNCTIONAL TESTING. ROOT CAUSE INVESTIGATION IS UNDERWAY. NO ADVERSE EVENT RESULTED FROM THE DAMAGED MONITOR.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION OF MONITOR HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 102) HAS BEEN CONFIRMED. UPON INVESTIGATION THE MONITOR FAILED A PULSE TEST AND DISPLAYED A SERVICE CODE 102 (CHARGE PROFILE FAULT). THE CAUSE FOR THE FAILURE WAS ISOLATED TO AN OPEN R45 RESISTOR ON THE COMPUTER/ANALOG BOARD. THE ROOT CAUSE FOR THE OPEN R45 RESISTOR COULD NOT BE POSITIVELY IDENTIFIED. THERE WAS NO ADVERSE EVENT THAT RESULTED FROM THE DSAMAGED MONITOR. DEVICE EVALUATION OF MONITOR IS UNDERWAY. THE REPORTED PROBLEM (SERVICE CODE 102) HAS BEEN CONFIRMED. UPON INVESTIGATION THE MONITOR WAS DISPLAYING A SERVICE CODE 102 AND FAILED INCOMING FUNCTIONAL TESTING. ROOT CAUSE INVESTIGATION IS UNDERWAY. NO ADVERSE EVENT RESULTED FROM THE DAMAGED MONITOR.

    Description of Event or Problem · 0

    A US DISTRIBUTOR RETURNED A MONITOR AND REPORTED THE MONITOR DISPLAYED A SERVICE CODE 102 (CHARGE PROFILE FAULT) AND FAILED INCOMING TESTING.

    Description of Event or Problem · 0

    A US DISTRIBUTOR RETURNED A MONITOR AND REPORTED THE MONITOR DISPLAYED A SERVICE CODE 102 (CHARGE PROFILE FAULT) AND FAILED INCOMING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784119 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown