BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 - AMER

    MDR report key: 17968797 · Received October 19, 2023

    Report

    Report Number
    3007573469-2023-00586
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Date of Event
    September 19, 2023
    Report Date
    October 19, 2023
    Manufacturer
    RESMED LTD
    Product Code
    NOU
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASTRAL DEVICE WAS RETURNED TO RESMED. EVALUATION CONFIRMED THE REPORTED COMPLAINT. THE MAIN CIRCUIT BOARD WILL BE REPLACED TO ADDRESS THE ISSUE. RESMED REFERENCE#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF179) RELATED TO THE SUPER CAPACITOR. THE DEVICE WAS NOT IN PATIENT USE WHEN THE REPORTED EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653382 ASTRAL 150 - AMER VENTILATOR, CONTINUOUS (FACILITY/HOME) NOU RESMED LTD 27003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown