BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 100 - APAC2

    MDR report key: 18008203 · Received October 25, 2023

    Report

    Report Number
    3004604967-2023-00619
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    September 13, 2023
    Report Date
    October 25, 2023
    Manufacturer
    RESMED LTD
    Product Code
    NOU
    UDI-DI
    00619498270828
    PMA / PMN Number
    K172875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASTRAL DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. EVALUATION CONFIRMED THE REPORTED COMPLAINT. THE TOP CASE ASSEMBLY 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 HAD AN UNRESPONSIVE TOUCHSCREEN. 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
    2174576 ASTRAL 100 - APAC2 VENTILATOR, CONTINUOUS (FACILITY/HOME) NOU RESMED LTD 27082 00619498270828

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown