BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLAR 100 - UK

    MDR report key: 4342607 · Received November 7, 2014

    Report

    Report Number
    3007573469-2014-00027
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Date of Event
    October 3, 2014
    Report Date
    November 7, 2014
    Manufacturer
    RESMED GERMANY INC.
    Product Code
    MNT
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED (B)(4) THAT A STELLAR 100 TURNED OFF DURING THERAPY. PER REPORTER, THE PATIENT VENTILATOR SWITCHED OFF DURING USE WITH NO ALARM OR PRIOR WARNING. THE CHILD RECEIVED LIMITED VENTILATION RESULTING IN A FALL IN OXYGEN LEVEL RECORDED AT 48%. THE PATIENT WAS IMMEDIATELY ADMINISTERED WITH VENTILATION VIA AMBU BAG AND 15 LITERS OF OXYGEN UNTIL ANOTHER VENTILATOR WAS SET UP. THE PATIENT'S STATS RETURNED TO NORMAL AFTER THE PATIENT WAS PUT IN ANOTHER VENTILATOR. REF MFR 3004604967-2014-00038.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719755 STELLAR 100 - UK CONTINUOUS VENTILATOR (FACILITY USE) MNT RESMED GERMANY INC. 24155

    Patients

    Seq Age Sex Outcome Treatment
    1