BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 - DEU

    MDR report key: 17968017 · Received October 19, 2023

    Report

    Report Number
    3004604967-2023-00583
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Date of Event
    September 19, 2023
    Report Date
    May 2, 2024
    Manufacturer
    RESMED LTD
    Product Code
    NOU
    PMA / PMN Number
    K172875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON ALL AVAILABLE EVIDENCE AND COMPLAINT INVESTIGATIONS OF A SIMILAR NATURE, THE INVESTIGATION DETERMINED THAT SF82 AND SF140 WERE DUE TO SUPER CAPACITOR LEAK AND CONTAMINATION. RESMED¿S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE#: (B)(4).

    Additional Manufacturer Narrative · 0

    THE ASTRAL DEVICE WAS RETURNED TO RESMED. EVALUATION CONFIRMED THE REPORTED COMPLAINT AND REVEALED AN ERROR MESSAGE (SF82) RELATED TO THE ALARM SYSTEM. VISUAL INSPECTION REVEALED DUST WITHIN THE DEVICE AND SUPER CAPACITOR LEAK ON THE MAIN CIRCUIT BOARD. THE MAIN CIRCUIT BOARD WAS REPLACED TO ADDRESS THE ISSUES. RESMED REFERENCE#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF140) RELATED TO ALARM PRIORITY. 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 DISPLAYED AN ERROR MESSAGE (SF140) RELATED TO ALARM PRIORITY. 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
    1738873 ASTRAL 150 - DEU VENTILATOR, CONTINUOUS (FACILITY/HOME) NOU RESMED LTD 27053

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown