BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESIPRATORY HUMDIFIER HEATER - 100-120V WITH NEMA 5-15P 3 PIN PLUG

    MDR report key: 13042628 · Received December 20, 2021

    Report

    Report Number
    3006061749-2021-00012
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    November 29, 2021
    Report Date
    December 20, 2021
    Manufacturer
    GREAT GROUP MEDICAL CO LTD
    Product Code
    BTT
    PMA / PMN Number
    K161314
    Removal / Correction Number
    MW5105695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS BEING RETURNED FOR EVALUATION. ONCE RETURNED AN INVESTIGATION INTO ROOT CAUSE WILL BE CONDUCTED.

    Description of Event or Problem · 0

    THE HEATER WAS NOT HEATING AND ALARMING. THE FACILITY TURNED IT OFF AND UNPLUGGED THE HEATER, THEY PLUGGED INTO A DIFFERENT OUTLET AND TURNED IT BACK ON AND IT SEEMED TO WORK FINE AND HEAT UP. THEY CHANGED IT TO NIV MODE AND PATIENT STARTED POINTING TO HEATER BECAUSE IT HAD SMOKE COMING OUT OF IT, THEN CAUGHT ON FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1940198 RESIPRATORY HUMDIFIER HEATER - 100-120V WITH NEMA 5-15P 3 PIN PLUG RESPIRATORY HUMDIFIER HEATER BTT GREAT GROUP MEDICAL CO LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown