BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 100 - EUR1

    MDR report key: 17977111 · Received October 20, 2023

    Report

    Report Number
    3007573469-2023-00590
    Event Type
    Malfunction
    Date Received
    October 20, 2023
    Date of Event
    September 20, 2023
    Report Date
    October 20, 2023
    Manufacturer
    RESMED LTD
    Product Code
    NOU
    UDI-DI
    00619498270118
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PL
    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 DEVICE WAS RECALIBRATED 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 (SF188) INDICATING A SAFETY ASSERT SYSTEM FAULT. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121783 ASTRAL 100 - EUR1 VENTILATOR, CONTINUOUS (FACILITY/HOME) NOU RESMED LTD 27011 00619498270118

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown