BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLAR 150

    MDR report key: 4195350 · Received September 25, 2014

    Report

    Report Number
    3007573469-2014-00011
    Event Type
    Injury
    Date Received
    September 25, 2014
    Date of Event
    August 26, 2014
    Report Date
    September 25, 2014
    Manufacturer
    RESMED GERMANY INC.
    Product Code
    MNT
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED UK THAT A PATIENT WAS FOUND CYANOSED WITH AN SPO2 OF 50-60% BY A NURSE AT 7:28 AM. AT THE TIME THE PATIENT WAS FOUND THE BATTERY OF THE DEVICE WAS EMPTY AND THE POWER CABLE WASN'T ATTACHED. PER THE REPORTER THE PATIENT WAS BEING VENTILATED DURING NIGHT AND AT SOME POINT THE DEVICE POWER CABLE BECAME DISCONNECTED. IT WAS REPORTED THAT THE POWER CABLE WAS CAUGHT UNDER THE WHEELS OF THE PATIENT'S BED. MFR REF # 3004604967-2014-00022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599678 STELLAR 150 CONTINUOUS VENTILATOR MNT RESMED GERMANY INC. 24145

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention