BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 - AMER

    MDR report key: 6012874 · Received October 7, 2016

    Report

    Report Number
    3004604967-2016-01093
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Report Date
    August 29, 2017
    Manufacturer
    RESMED LTD
    Product Code
    CBK
    UDI-DI
    00619498270033
    PMA / PMN Number
    K133868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASTRAL DEVICE WAS RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. REVIEW OF THE DEVICE LOGS AND PERFORMANCE TESTING CONFIRMED THE OCCURRENCE OF THE REPORTED SYSTEM FAULT 74. REVIEW OF THE DEVICE DATA LOGS ALSO REVEALED THE OCCURRENCE OF SYSTEM FAULTS 218 AND 195. BASED ON ALL AVAILABLE EVIDENCE AND COMPLAINT INVESTIGATIONS OF A SIMILAR NATURE, THE INVESTIGATION DETERMINED THAT THE SYSTEM FAULTS 218 AND 195 WERE DUE TO SOFTWARE ISSUES. THE INVESTIGATION ALSO DETERMINED THAT THE SYSTEM FAULT 74 WAS MOST LIKELY DUE TO A HARDWARE CONNECTION ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. THE DEVICE WAS NOT IN USE AT THE TIME OF THE EVENTS, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. RESMED REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY BEING RETURNED TO THE RESMED DESIGN HOUSE LOCATED IN (B)(4) FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF74) INDICATING A SOFTWARE TASK FAULT AND SUBSEQUENTLY PERFORMED A SAFETY RESTART. THE DEVICE WAS NOT DELIVERING THERAPY AT THE TIME OF THE EVENT AND THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF74) INDICATING A SOFTWARE TASK FAULT AND SUBSEQUENTLY PERFORMED A SAFETY RESTART. THE DEVICE WAS NOT DELIVERING THERAPY AT THE TIME OF THE EVENT AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663756 ASTRAL 150 - AMER CBK RESMED LTD 27003 00619498270033

    Patients

    Seq Age Sex Outcome Treatment
    1