BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 -EUR4

    MDR report key: 18151803 · Received November 16, 2023

    Report

    Report Number
    3007573469-2023-00641
    Event Type
    Malfunction
    Date Received
    November 16, 2023
    Date of Event
    October 18, 2023
    Report Date
    July 17, 2024
    Manufacturer
    RESMED LTD
    Product Code
    NOU
    UDI-DI
    00619498270637
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    BU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED BY RESMED AND AN EVALUATION CONFIRMED THE COMPLAINT. THE TOP CASE 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, AN INVESTIGATION DETERMINED THAT THE REPORTED COMPLAINT WAS DUE TO PHYSICAL DAMAGE OF THE LCD MODULE THAT LED TO AN OPEN CIRCUIT IN THE RESISTIVE TRACKS. 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 HAD AN UNRESPONSIVE TOUCHSCREEN. THE DEVICE WAS NOT IN PATIENT USE WHEN THE REPORTED EVENT OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD AN UNRESPONSIVE TOUCHSCREEN. THE DEVICE WAS NOT IN PATIENT USE WHEN THE REPORTED EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545807 ASTRAL 150 -EUR4 VENTILATOR, CONTINUOUS (FACILITY/HOME) NOU RESMED LTD 27063 00619498270637

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown