BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLAR 100 - UK

    MDR report key: 3784360 · Received April 24, 2014

    Report

    Report Number
    3007573469-2014-00001
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    December 1, 2013
    Report Date
    April 24, 2014
    Manufacturer
    RESMED GERMANY INC
    Product Code
    MNT
    Adverse Event
    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 THE VENTILATION HOSE DISCONNECTED FROM THE STELLAR 100 UNIT AND WHEN RECONNECTED, IT DELIVERED A HIGH PRESSURE TO THE PT'S TRACHEOSTOMY CAUSING TRAUMA. PER REPORTER, WHEN THE MOM OF A 24/7 VENTILATION DEPENDENT CHILD WAS MOVING HIM FORM 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 PT HAS AN INFLATED CUFF AROUND HIS TRACHEOSTOMY, THERE WAS NO ESCAPE FOR THE PRESSURE AND THE PT SUSTAINED SOME TRAUMA SHOWN BY BLOOD STAINED SECRETIONS THROUGHOUT THE NIGHT. AT THIS TIME, THERE APPEARED TO BE NO OTHER CLINICAL CHANGE. REFERENCE MFR # 3004604967-2014-00012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248410 STELLAR 100 - UK MNT RESMED GERMANY INC 24155

    Patients

    Seq Age Sex Outcome Treatment
    1 21 MO Other