BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASTRAL 100 - EUR4

    MDR report key: 14402863 · Received May 14, 2022

    Report

    Report Number
    3004604967-2022-00341
    Event Type
    Death
    Date Received
    May 14, 2022
    Report Date
    July 1, 2022
    Manufacturer
    RESMED LTD
    Product Code
    CBK
    PMA / PMN Number
    K172875
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    BASED ON ADDITIONAL INFORMATION RECEIVED, THIS IS A DUPLICATE OF (B)(4). ENGINEERING INVESTIGATION FINDINGS FOR THE REPORTED EVENT WERE SUBMITTED IN REPORT NUMBER 3004604967-2021-00935/3007573469-2021-00935 ASSOCIATED WITH (B)(4). RESMED REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT A PATIENT USING AN ASTRAL DEVICE PASSED AWAY. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE TO RESMED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT A PATIENT USING AN ASTRAL DEVICE PASSED AWAY. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE TO RESMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475635 ASTRAL 100 - EUR4 CBK RESMED LTD 27061

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death