BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 - DEU

    MDR report key: 5150372 · Received October 14, 2015

    Report

    Report Number
    3004604967-2015-00506
    Event Type
    Malfunction
    Date Received
    October 14, 2015
    Date of Event
    September 15, 2015
    Report Date
    October 13, 2015
    Manufacturer
    RESMED LTD
    Product Code
    NOU
    PMA / PMN Number
    K133868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY THE RESMED TECHNICAL SERVICE CENTER IN (B)(4) AND AN EVALUATION WAS PERFORMED. THE EVALUATION DETERMINED THAT THE DEVICE FAILURE TO COMPLETE ITS INTERNAL SELF-TEST WAS DUE TO A DEFECTIVE PNEUMATIC BLOCK. THE PNEUMATIC BLOCK WAS REPLACED TO ADDRESS THIS ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED (B)(4) THAT AN ASTRAL DEVICE FAILED TO PASS ITS INTERNAL SELF-TEST. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679836 ASTRAL 150 - DEU VENTILATOR, CONTINUOUS (FACILITY/HOME) NOU RESMED LTD 27053

    Patients

    Seq Age Sex Outcome Treatment
    1