BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 - DEU

    MDR report key: 5442542 · Received February 17, 2016

    Report

    Report Number
    3004604967-2016-00116
    Event Type
    Malfunction
    Date Received
    February 17, 2016
    Date of Event
    January 18, 2016
    Report Date
    May 23, 2017
    Manufacturer
    RESMED LTD
    Product Code
    NOU
    PMA / PMN Number
    K133868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) FOR EVALUATION. THE EVALUATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 1

    THE ASTRAL DEVICE WAS RETURNED TO RESMED AND AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED. REVIEW OF THE DEVICE LOGS CONFIRMED THE REPORTED UNEXPECTED RESTART AND REVEALED SYSTEM FAULT ERROR MESSAGES (SF 101, 133, 218, AND 74). BASED ON ALL AVAILABLE EVIDENCE AND COMPLAINT INVESTIGATIONS OF A SIMILAR NATURE, THE INVESTIGATION DETERMINED THAT THE REPORTED EVENT WAS MOST LIKELY DUE TO CONTAMINATION OF THE DEVICE AND A SOFTWARE ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT. RESMED REFERENCE#: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE RESTARTED UNEXPECTEDLY AND DISPLAYED A RED SCREEN. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99135 ASTRAL 150 - DEU VENTILATOR, CONTINUOUS (FACILITY/HOME) NOU RESMED LTD 27053

    Patients

    Seq Age Sex Outcome Treatment
    1