BEUDAMED
    FDA Adverse Event Death Summary report: N

    REM AUTO A-FLEX

    MDR report key: 20452939 · Received October 15, 2024

    Report

    Report Number
    2518422-2024-62603
    Event Type
    Death
    Date Received
    October 15, 2024
    Date of Event
    February 19, 2024
    Report Date
    October 8, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY RECEIVED INFORMATION RELATED TO A REMSTAR AUTO A-FLEX DEVICE. THE PATIENT HAS PREVIOUSLY ALLEGEDLY PASSED AWAY. THERE WAS NO ALLEGATION OF MALFUNCTION OR THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, THERE IS NO PATIENT INFORMATION AVAILABLE; THEREFORE, NO GOOD FAITH EFFORT ATTEMPTS CAN BE MADE, AND PHILIPS IS NOT ABLE TO FULLY INVESTIGATE THIS COMPLAINT. IF ANY ADDITIONAL INFORMATION IS RECEIVED OR THE DEVICE IS RETURNED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION REGARDING A REM AUTO A-FLEX SYSONE. THE MANUFACTURER RECEIVED INFORMATION ALLEGING PATIENT PASSED AWAY. AT THIS TIME MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37044 REM AUTO A-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. RIN561S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death