BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 - APAC2

    MDR report key: 18233901 · Received November 29, 2023

    Report

    Report Number
    3007573469-2023-00658
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    November 6, 2023
    Report Date
    April 25, 2024
    Manufacturer
    RESMED PTY LTD
    Product Code
    NOU
    UDI-DI
    00619498270880
    Product Problem
    Yes
    Report Source
    Distributor 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 MAIN CIRCUIT BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS SERVICED AND FULLY TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED REFERENCE#: (B)(4).

    Additional Manufacturer Narrative · 0

    BASED ON ALL AVAILABLE EVIDENCE AND COMPLAINT INVESTIGATIONS OF A SIMILAR NATURE, THE INVESTIGATION DETERMINED THAT THE REPORTED COMPLAINT WAS DUE TO A MANUFACTURING DEFECT. RESMED¿S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE#: PR (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.

    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
    2181040 ASTRAL 150 - APAC2 VENTILATOR, CONTINUOUS (FACILITY/HOME) NOU RESMED PTY LTD 27088 00619498270880

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown