BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 - FUKUDA

    MDR report key: 20015753 · Received August 21, 2024

    Report

    Report Number
    3007573469-2024-00260
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    June 18, 2024
    Report Date
    November 26, 2024
    Manufacturer
    RESMED PTY LTD
    Product Code
    NOU
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASTRAL DEVICE WAS RETURNED TO RESMED FOR AN INVESTIGATION. REVIEW OF THE DEVICE DATA LOGS CONFIRMED THE REPORTED COMPLAINT; HOWEVER, THE ALARM COULD NOT BE REPRODUCED. PERFORMANCE TESTING REVEALED AN ERROR MESSAGE (SF140) RELATED TO ALARM PRIORITY AND ERROR MESSAGE (SF82) RELATED TO THE ALARM SYSTEM. VISUAL INSPECTION OF THE MAIN CIRCUIT BOARD REVEALED AN ELECTROLYTE LEAK ON THE SUPER CAPACITOR. BASED ON ALL AVAILABLE EVIDENCE AND COMPLAINT INVESTIGATIONS OF A SIMILAR NATURE, THE INVESTIGATION DETERMINED THAT THE REPORTED TOTAL POWER FAILURE ALARM WAS DUE TO AN INTERMITTENT SIGNAL BETWEEN THE BATTERY AND MAIN CIRCUIT BOARD WHILE SF140 AND SF82 WERE DUE TO A LEAKING CAPACITOR ON THE MAIN CIRCUIT BOARD. RESMED¿S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE IS CURRENTLY BEING RETURNED TO RESMED FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. IF MORE INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. RESMED REFERENCE #: PR 3130282

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED A TOTAL POWER FAILURE ALARM ACCOMPANIED BY SAFETY RESET ALARM WHILE THE INTERNAL BATTERY INDICATOR WAS 90%. THERE WAS NO HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THE INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED A TOTAL POWER FAILURE ALARM WHILE THE INTERNAL BATTERY INDICATOR WAS 90%. THERE WAS NO HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2287089 ASTRAL 150 - FUKUDA VENTILATOR, CONTINUOUS (FACILITY/HOME) NOU RESMED PTY LTD 27093

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown