BEUDAMED
    FDA Adverse Event Death Summary report: N

    REM STAR AUTO A-FLEX

    MDR report key: 20627748 · Received November 7, 2024

    Report

    Report Number
    2518422-2024-68706
    Event Type
    Death
    Date Received
    November 7, 2024
    Date of Event
    October 9, 2023
    Report Date
    November 7, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959030497
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING DEATH. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. MAXIMUM ATTEMPTS WERE MADE TO HAVE THE DEVICE RETURNED FOR EVALUATION, INVESTIGATION AND TO GATHER ADDITIONAL INFORMATION BUT WERE UNSUCCESSFUL. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE REQUESTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417925 REM STAR AUTO A-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 560P 00606959030497

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death