BEUDAMED
    FDA Adverse Event Death Summary report: N

    I-NEB CF UK UNIT

    MDR report key: 21688986 · Received March 25, 2025

    Report

    Report Number
    2518422-2025-038523
    Event Type
    Death
    Date Received
    March 25, 2025
    Date of Event
    December 21, 2023
    Report Date
    July 2, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CAF
    UDI-DI
    00383730000909
    PMA / PMN Number
    K102454
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT WITH AN I-NEB CF UK UNIT DEVICE HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THE DEVICE WAS RETURNED AS NO LONGER NEEDED AND WAS SCRAPPED WITHOUT TESTING. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED. IN THIS REPORT, BOX D, G, H HAS BEEN CORRECTED.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF AN ALLEGATION OF I-NEB CF UK UNIT ALLEGES DEATH - PATIENT NO LONGER USING INEB DEVICE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER¿S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320108 I-NEB CF UK UNIT NEBULIZER CAF RESPIRONICS, INC. 1083220 00383730000909

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death