BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 100 - AMER

    MDR report key: 18414691 · Received December 28, 2023

    Report

    Report Number
    3007573469-2023-00704
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    December 1, 2023
    Report Date
    December 28, 2023
    Manufacturer
    RESMED PTY LTD
    Product Code
    NOU
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, 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 PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS SERVICED AND FULLY TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED REFERENCE#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF147) RELATED TO THE MAIN BLOWER. THE DEVICE WAS NOT IN PATIENT USE WHEN THE REPORTED EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401037 ASTRAL 100 - AMER VENTILATOR, CONTINUOUS (FACILITY/HOME) NOU RESMED PTY LTD 27001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown