BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS CPAP DEVICE

    MDR report key: 17672322 · Received September 1, 2023

    Report

    Report Number
    2518422-2023-21579
    Event Type
    Death
    Date Received
    September 1, 2023
    Date of Event
    August 28, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ONLY INFORMATION PROVIDED FOR THE DEVICE IS (B)(6). THIS IS AN INVALID SERIAL NUMBER, AND NO DEVICE INFORMATION IS AVAILABLE. PRODUCT BRAND NAME -PHILIPS CPAP DEVICE WITH AN FDA PRODUCT CODE OF BZD, AND COMMON DEVICE NAME- VENTILATOR, NON-CONTINUOUS (RESPIRATOR) HAS BEEN USED AS A SUBSTITUTE FOR THE UNKNOWN INFORMATION. H3 OTHER TEXT: DEVICE NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION FROM PHILIPS LEGAL REGARDING LITIGATION. THE INFORMATION RECEIVED ALLEGES DEATH OCCURRED. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. 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
    1869744 PHILIPS CPAP DEVICE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death