BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASTRAL 150-DEU

    MDR report key: 4356207 · Received October 10, 2014

    Report

    Report Number
    3007573469-2014-00015
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 16, 2014
    Report Date
    October 10, 2014
    Manufacturer
    RESMED LTD,
    Product Code
    NOU
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED GERMANY THAT A PATIENT BEING VENTILATED ON AN ASTRAL DEVICE WAS FOUND MOTIONLESS WITH A CARDIAC ARREST. PER THE REPORTER, "DURING THE ROUTINE VIGILANCE ROUND BY THE CLINICIAN THE PATIENT WAS FOUND DISCONNECTED FROM THE VENTILATOR BREATHING SYSTEM, MOTIONLESS WITH A CARDIAC ARREST. IMMEDIATE INITIATED RESUSCITATION WITH DEFIBRILLATION WAS SUCCESSFUL. THE PATIENT WAS BEING VENTILATED IN AN NIV MODE WITH THE DISCONNECTION ALARM / HYPO-VENTILATION ALARM SWITCHED TO THE OFF POSITION RESULTING IN NO ALARM SIGNAL INITIATED WHEN THE DISCONNECTION OF THE PATIENT OCCURRED". MFR REF#: 3004604967-2014-00026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643445 ASTRAL 150-DEU VENTILATOR, CONTINUOUS (FACILITY/HOME), NOU, CBK NOU RESMED LTD, 27053

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention