BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 - AMER

    MDR report key: 4609819 · Received March 5, 2015

    Report

    Report Number
    3007573469-2015-00061
    Event Type
    Malfunction
    Date Received
    March 5, 2015
    Date of Event
    February 1, 2015
    Report Date
    March 5, 2015
    Manufacturer
    RESMED LTD
    Product Code
    NOU
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE TRIGGERED AUDIBLE ALARMS THAT NOTIFIED THE USER OF AN EXPIRATORY MINUTE VOLUME (MVE) ISSUE. PER THE REPORTER THE PT WAS HAVING PROBLEMS WITH LEAK. THERE WAS NO PT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR #3004604967-2015-00061.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152913 ASTRAL 150 - AMER VENTILATOR, CONTINUOUS (FACILITY/HOME) NOU RESMED LTD 27003

    Patients

    Seq Age Sex Outcome Treatment
    1