BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 - AMER

    MDR report key: 20252280 · Received September 18, 2024

    Report

    Report Number
    3007573469-2024-00290
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    August 22, 2024
    Report Date
    September 18, 2024
    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 DEVICE WAS RETURNED TO RESMED AND AN EVALUATION CONFIRMED THE COMPLAINT. VISUAL INSPECTION REVEALED A BROKEN WIRE ON THE MOTOR CAPACITOR AND A DAMAGED MOTOR CAPACITOR CONNECTOR PIN ON THE MAIN CIRCUIT BOARD. THE MAIN CIRCUIT BOARD AND MOTOR CAPACITOR WERE REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS SERVICED AND FULLY TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED REFERENCE #: PR 3151006

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF147) RELATED TO THE MAIN BLOWER. THERE WAS NO HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2532802 ASTRAL 150 - AMER VENTILATOR, CONTINUOUS (FACILITY/HOME) NOU RESMED PTY LTD 27003 00619498270033

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown