BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REP DREAMSTATION AUTO BIPAP

    MDR report key: 20047860 · Received August 23, 2024

    Report

    Report Number
    2518422-2024-53062
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    October 12, 2023
    Report Date
    August 23, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959025707
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 PATIENT IS ALLEGING EYE IRRITATION, DIZZINESS, HEADACHE, LIVER DISEASE/TOXICITY. AT THIS TIME, NO MEDICAL INTERVENTION HAS BEEN REPORTED. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312303 REP DREAMSTATION AUTO BIPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. UDSX700S11F 00606959025707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other