BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLAR 100 - UK

    MDR report key: 3690548 · Received March 13, 2014

    Report

    Report Number
    3004604967-2014-00007
    Event Type
    Injury
    Date Received
    March 13, 2014
    Date of Event
    February 25, 2014
    Report Date
    March 13, 2014
    Manufacturer
    RESMED GERMANY INC.
    Product Code
    MNT
    PMA / PMN Number
    K122715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY RESMED (B)(4) AND IS BEING RETURNED TO THE DESIGN FACILITY IN GERMANY FOR AN ENGINEERING INVESTIGATION. AS INDICATED BY THE REPORTER, THE DEVICE WAS USED FOR A VENTILATOR-DEPENDENT PATIENT WHILE THE INTENDED USE IS LIMITED TO NON-DEPENDENT PATIENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED (B)(4) THAT THE VENTILATION HOSE DISCONNECTED FROM THE STELLAR 100 UNIT AND WHEN RECONNECTED, IT DELIVERED A HIGH PRESSURE TO THE PATIENT'S TRACHEOSTOMY CAUSING TRAUMA. PER REPORTER, WHEN THE MOM OF A 24/7 VENTILATION DEPENDENT CHILD WAS MOVING HIM FROM THE LOUNGE TO HIS BEDROOM, THE VENTILATION CIRCUIT BECAME DISCONNECTED AT THE VENTILATOR END. THE MOM IMMEDIATELY RECONNECTED THE HOSE BACK ON THE DEVICE AND A HIGH PRESSURE BREATH WAS DELIVERED. SINCE THE PATIENT HAS AN INFLATED CUFF AROUND HIS TRACHEOSTOMY, THERE WAS NO ESCAPE FOR THE PRESSURE AND THE PATIENT SUSTAINED SOME TRAUMA SHOWN BY BLOOD STAINED SECRETIONS THROUGHOUT THE NIGHT. AT THIS TIME, THERE APPEARED TO BE NO OTHER CLINICAL CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152057 STELLAR 100 - UK MNT RESMED GERMANY INC. 24155

    Patients

    Seq Age Sex Outcome Treatment
    1 23 MO Other