BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTE CAPTEUR BLOC PNEUMATIQUE - ASTRAL

    MDR report key: 18007455 · Received October 25, 2023

    Report

    Report Number
    3004604967-2023-00609
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    September 26, 2023
    Report Date
    July 17, 2024
    Manufacturer
    RESMED LTD
    Product Code
    NOU
    UDI-DI
    00619498196371
    PMA / PMN Number
    K172875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASTRAL DEVICE PNEUMATIC BLOCK SENSOR CIRCUIT BOARD WAS RETURNED TO RESMED FOR AN INVESTIGATION. PERFORMANCE TESTING CONFIRMED THE REPORTED COMPLAINT. BASED ON ALL AVAILABLE EVIDENCE AND COMPLAINT INVESTIGATIONS OF A SIMILAR NATURE, THE INVESTIGATION DETERMINED THAT THE REPORTED COMPLAINT WAS DUE TO OPERATOR ERROR. RESMED¿S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE#: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO RESMED FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. IF FURTHER INFORMATION BECOMES AVAILABLE, A SUPPLEMENTARY REPORT WILL BE SUBMITTED. RESMED REFERENCE#: (B)(4). H3 OTHER TEXT : DEVICE RECEIVED; INVESTIGATION PENDING.

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF75) RELATED TO PNEUMATIC BLOCK CALIBRATION AFTER REPLACEMENT OF ITS PNEUMATIC BLOCK SENSOR CIRCUIT BOARD. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF75) RELATED TO PNEUMATIC BLOCK CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1838911 CARTE CAPTEUR BLOC PNEUMATIQUE - ASTRAL VENTILATOR, CONTINUOUS (FACILITY/HOME) NOU RESMED LTD 19637 00619498196371

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown