BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 DBL KIT FRA

    MDR report key: 4834225 · Received June 3, 2015

    Report

    Report Number
    3004604967-2015-00179
    Event Type
    Malfunction
    Date Received
    June 3, 2015
    Report Date
    May 27, 2016
    Manufacturer
    RESMED LTD.
    Product Code
    NOU
    PMA / PMN Number
    K133868
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY THE RESMED MANUFACTURING FACILITY LOCATED IN (B)(6) AND AN EXTENSIVE INVESTIGATION WAS PERFORMED. THE INVESTIGATION DETERMINED THAT THE BATTERY ISSUE WAS DUE TO A SOFTWARE PROBLEM. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360722 ASTRAL 150 DBL KIT FRA VENTILATOR, CONTINUOUS (FACILITY/HOME) CBK NOU RESMED LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1