BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PMG-ADVANCED

    MDR report key: 18836099 · Received March 5, 2024

    Report

    Report Number
    18836099
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Date of Event
    February 19, 2024
    Report Date
    February 19, 2024
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    GXI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PRIOR TO THE START OF A SCHEDULED PROCEDURE, THE RF MACHINE WOULD NOT TURN ON. THE MACHINE WAS REBOOTED AND PLUGGED INTO A DIFFERENT OUTLET, BUT STILL FAILED TO TUN ON. THE MACHINE HAD BEEN TURNED ON AND TESTED EARLIER AND WORKED CORRECTLY. MANUFACTURER RESPONSE FOR PAIN MANAGEMENT GENERATOR, PMG-ADVANCED (PER SITE REPORTER), RETURNING DEVICE WITH ONSITE REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519651 PMG-ADVANCED PROBE, RADIOFREQUENCY LESION GXI AVANOS MEDICAL, INC. PMG-ADVANCED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown