BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASTRAL 150 - AMER

    MDR report key: 11843447 · Received May 18, 2021

    Report

    Report Number
    3007573469-2021-00612
    Event Type
    Death
    Date Received
    May 18, 2021
    Date of Event
    April 19, 2021
    Report Date
    May 18, 2021
    Manufacturer
    RESMED LTD
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT AN ENGINEERING INVESTIGATION COULD BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED, THEREFORE RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. RESMED REFERENCE#: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A PATIENT USING AN ASTRAL DEVICE DECANNULATED AND THE NURSE WAS UNABLE TO PROVIDE ASSISTANCE WITH THE TRACH. THE PATIENT SUBSEQUENTLY EXPIRED. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE TO RESMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737229 ASTRAL 150 - AMER CBK RESMED LTD 27003

    Patients

    Seq Age Sex Outcome Treatment
    1 Death