BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLAR 100 - UK

    MDR report key: 4342195 · Received November 7, 2014

    Report

    Report Number
    3004604967-2014-00038
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Manufacturer
    RESMED GERMANY INC.
    Product Code
    MNT
    PMA / PMN Number
    K122715
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENGINEERING INVESTIGATION OF THE RETURNED UNIT DETERMINED THE DEVICE WAS SWITCHED OFF MANUALLY. THERE WAS NO FAULT FOUND. THE UNIT WAS WORKING CORRECTLY AND ACCORDING TO SPECIFICATION. AS INDICATED BY THE REPORTER, THE DEVICE WAS USED FOR A VENTILATOR-DEPENDENT PATIENT WHILE THE INTENDED USE IS LIMITED TO NON-DEPENDENT PATIENTS. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718460 STELLAR 100 - UK CONTINUOUS VENTILATOR (FACILITY USE) MNT RESMED GERMANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1