BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLAR 100 - UK

    MDR report key: 3784359 · Received April 24, 2014

    Report

    Report Number
    3004604967-2014-00012
    Event Type
    Injury
    Date Received
    April 24, 2014
    Manufacturer
    RESMED GERMANY INC
    Product Code
    MNT
    PMA / PMN Number
    K122715
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION METHODS, RESULTS AND CONCLUSIONS ARE NOT FINALIZED AT THIS STAGE. FROM THE STELLAR USER GUIDE. INDICATION FOR USE: THE STELLAR 100/150 IS INTENDED TO PROVIDE VENTILATION FOR NON-DEPENDENT, SPONTANEOUSLY BREATHING ADULT AND PEDIATRIC PTS (30 LB/13 KG AND ABOVE) WITH RESPIRATORY INSUFFICIENCY, OR RESPIRATORY FAILURE, WITH OR WITHOUT OBSTRUCTIVE SLEEP APNEA. CONTRAINDICATION: THE STELLAR IS CONTRAINDICATED IN PTS WHO ARE UNABLE TO ENDURE MORE THAN BRIEF INTERRUPTIONS IN VENTILATION. THE STELLAR IS NOT A LIFE SUPPORT VENTILATOR. AS INDICATED BY THE REPORTER, THE DEVICE WAS USED FOR A VENTILATOR-DEPENDENT PT WHILE INTENDED USE IS LIMITED TO NON-DEPENDENT PTS. THERE WERE TWO SEPARATE INCIDENTS THAT OCCURRED WITH THE SAME PT. THE FIRST INCIDENT OCCURRED IN (B)(6) 2013 WHICH IS REPORTED IN THIS MEDWATCH. THE SECOND INCIDENT OCCURRED IN (B)(6) 2014 AND WAS REPORTED TO THE FDA IN MEDWATCH 3004604967-2014-00007.

    Description of Event or Problem · 1

    REFERENCE IMP# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248854 STELLAR 100 - UK MNT RESMED GERMANY INC

    Patients

    Seq Age Sex Outcome Treatment
    1