BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASTRAL 150 - AMER

    MDR report key: 6134011 · Received November 29, 2016

    Report

    Report Number
    3004604967-2016-01260
    Event Type
    Death
    Date Received
    November 29, 2016
    Report Date
    November 29, 2016
    Manufacturer
    RESMED LTD
    Product Code
    NOU
    PMA / PMN Number
    K133868
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. RESMED REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A PATIENT EXPERIENCING STOMACH PAIN HAD EXPIRED WHILE USING AN ASTRAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784234 ASTRAL 150 - AMER NOU RESMED LTD 27003

    Patients

    Seq Age Sex Outcome Treatment
    1 Death