BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 - EUR1

    MDR report key: 4834151 · Received June 4, 2015

    Report

    Report Number
    3007573469-2015-00182
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    May 1, 2015
    Report Date
    June 4, 2015
    Manufacturer
    RESMED LDT
    Product Code
    NOU
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED (B)(4) THAT A SYSTEM FAULT (SF101) ERROR MESSAGE OCCURRED ON AN ASTRAL DEVICE INDICATING THAT THE OUTLET PRESSURE MEASUREMENT MAY BE INCORRECT. THE SYSTEM FAULT OCCURRED WHILE THE HOSPITAL MEDICAL STAFF WAS CHANGING THE PATIENT'S CIRCUITS WHEN THE DEVICE IS STILL IN THERAPY MODE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR #3004604967-2015-00182.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363600 ASTRAL 150 - EUR1 VENTILATOR, CONTINUOUS (FACILITY/HOME) CBK NOU RESMED LDT 27013

    Patients

    Seq Age Sex Outcome Treatment
    1