BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 - AMER

    MDR report key: 18194008 · Received November 22, 2023

    Report

    Report Number
    3007573469-2023-00644
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Date of Event
    October 25, 2023
    Report Date
    November 22, 2023
    Manufacturer
    RESMED PTY LTD
    Product Code
    NOU
    UDI-DI
    00619498270033
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, 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. VISUAL INSPECTION OF THE SUPER CAPACITOR REVEALED ELECTROLYTE LEAKAGE. BASED ON ALL AVAILABLE EVIDENCE AND COMPLAINT INVESTIGATIONS OF A SIMILAR NATURE, AN INVESTIGATION DETERMINED THAT THE REPORTED COMPLAINT WAS DUE TO SUPER CAPACITOR ELECTROLYTE LEAK. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF179) RELATED TO THE SUPER CAPACITOR. 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
    1944123 ASTRAL 150 - AMER VENTILATOR, CONTINUOUS (FACILITY/HOME) NOU RESMED PTY LTD 27003 00619498270033

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown