BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 100 - AMER

    MDR report key: 17931940 · Received October 13, 2023

    Report

    Report Number
    3004604967-2023-00569
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Date of Event
    September 14, 2023
    Report Date
    October 13, 2023
    Manufacturer
    RESMED LTD
    Product Code
    NOU
    UDI-DI
    00619498270019
    PMA / PMN Number
    K172875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASTRAL DEVICE HAS NOT BEEN RETURNED TO RESMED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. RESMED REFERENCE#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE FAILED TO CHARGE ITS INTERNAL BATTERY. 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
    1969470 ASTRAL 100 - AMER VENTILATOR, CONTINUOUS (FACILITY/HOME) NOU RESMED LTD 27001 00619498270019

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown