BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 - DEU

    MDR report key: 4915491 · Received July 10, 2015

    Report

    Report Number
    3007573469-2015-00255
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 1, 2015
    Report Date
    July 10, 2015
    Manufacturer
    RESMED LTD
    Product Code
    NOU
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE HAD A LOW BATTERY CAUSING AN ALARM. THIS RESULTED IN AN INDEPENDENT SHUT DOWN OF THE DEVICE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR# 3004604967-2015-00255.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448359 ASTRAL 150 - DEU VENTILATOR, CONTINUOUS (FACILITY/HOME), NOU, CBK NOU RESMED LTD 27053

    Patients

    Seq Age Sex Outcome Treatment
    1