BEUDAMED
    FDA Adverse Event Death Summary report: N

    REM AUTO A-FLEX

    MDR report key: 23563534 · Received November 15, 2025

    Report

    Report Number
    2518422-2025-051958
    Event Type
    Death
    Date Received
    November 15, 2025
    Date of Event
    June 5, 2023
    Report Date
    May 14, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959030756
    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 REPORTED RECEIVING INFORMATION ALLEGING A PATIENT WITH A REM AUTO A-FLEX DEVICE HAS PASSED AWAY. THE REPORTED EVENT MAKES NO ALLEGATION OF ANY SPECIFIC DEVICE MALFUNCTION, USE ERROR, FAILURE, LABELING, OR OTHER DEFICIENCY THAT IS RELEVANT TO THE HARMS REPORTED; THEREFORE, BASED ON INFORMATION AVAILABLE AT THIS TIME, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. THIS NOTIFICATION WAS RE-EVALUATED FOLLOWING RECEIPT AND REVIEW OF ALL AVAILABLE INFORMATION RELATED TO THE REPORTED PATIENT DEATH. AT THE TIME OF INITIAL REPORTING, THE EVENT WAS CONSERVATIVELY SUBMITTED DUE TO THE LIMITED INFORMATION AVAILABLE. HOWEVER, SUBSEQUENT REVIEW CONFIRMS THAT THERE IS NO ALLEGATION OR EVIDENCE SUGGESTING THAT THE DEVICE MALFUNCTIONED, FAILED, OR OTHERWISE CONTRIBUTED TO THE REPORTED OUTCOME. THEREFORE, THIS CASE HAS BEEN REASSESSED AND DETERMINED TO BE NON-REPORTABLE. THE EVENT WILL CONTINUE TO BE DOCUMENTED AND TRENDED PER INTERNAL QUALITY SYSTEM REQUIREMENTS.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH A REM AUTO A-FLEX DEVICE HAS PASSED AWAY. THE REPORTED EVENT MAKES NO ALLEGATION OF ANY SPECIFIC DEVICE MALFUNCTION, USE ERROR, FAILURE, LABELING, OR OTHER DEFICIENCY THAT IS RELEVANT TO THE HARMS REPORTED; THEREFORE, BASED ON INFORMATION AVAILABLE AT THIS TIME, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560433 REM AUTO A-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. RIN561S 00606959030756

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death