BEUDAMED
    FDA Adverse Event Death Summary report: N

    REP DREAMSTATION AUTO BIPAP

    MDR report key: 22534655 · Received July 17, 2025

    Report

    Report Number
    2518422-2025-048200
    Event Type
    Death
    Date Received
    July 17, 2025
    Date of Event
    July 12, 2022
    Report Date
    July 17, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959063488
    PMA / PMN Number
    K131982
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION REGARDING A REP DREAMSTATION AUTO BIPAP. THE PATIENT HAS DIED OF HEART ATTACK. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. AN EXTERNAL AND INTERNAL VISUAL INSPECTION OF THE DEVICE WAS COMPLETED BY THE MANUFACTURER AND FOUND DUST-LIKE CONTAMINATION, HAIRLIKE MATERIALS, AN UNKNOWN CONTAMINANT, YELLOW COLORED CONTAMINATION TO THE DEVICE. THE MANUFACTURER FOUND LIQUID INGRESS TO THE BLOWER AND BLOWER BOX. THE MANUFACTURER ALSO FOUND BROWN COLORED CONTAMINATION, WHITE COLORED CONTAMINATION, FIBER LIKE CONTAMINATION, DUST CONTAMINATION AND LIQUID INGRESS IN THE HUMIDIFIER. THE MANUFACTURER CONCLUDES THERE WAS NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION. THE MANUFACTURER ALSO CONFIRMED LIQUID INGRESS TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808086 REP DREAMSTATION AUTO BIPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX700S11F 00606959063488

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death