BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 - AMER

    MDR report key: 17865447 · Received October 3, 2023

    Report

    Report Number
    3004604967-2023-00554
    Event Type
    Malfunction
    Date Received
    October 3, 2023
    Date of Event
    September 5, 2023
    Report Date
    October 3, 2023
    Manufacturer
    RESMED LTD
    Product Code
    NOU
    UDI-DI
    00619498270033
    PMA / PMN Number
    K172875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT AN INVESTIGATION CAN BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED. IF FURTHER INFORMATION BECOMES AVAILABLE, A SUPPLEMENTARY REPORT WILL BE SUBMITTED. RESMED REFERENCE#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF101) RELATED TO PRESSURE MEASUREMENT. 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
    1568533 ASTRAL 150 - AMER VENTILATOR, CONTINUOUS (FACILITY/HOME) NOU RESMED LTD 27003 00619498270033

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown