BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REP DREAMSTATION AUTO

    MDR report key: 19432147 · Received May 30, 2024

    Report

    Report Number
    2518422-2024-32762
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    May 2, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A REPAIRED DREAMSTATION AUTO BIPAP. THE MANUFACTURER RECEIVED INFORMATION ALLEGING DIZZINESS AND OR HEADACHE, ASTHMA (NEW WORSENING), LUNG DISEASE, COLON CANCER, COPD. MEDICAL INTERVENTION WAS NOT SPECIFIED. NO PATIENT INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. 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
    311824 REP DREAMSTATION AUTO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. UDSX700S11F

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other