BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS CPAP DEVICE

    MDR report key: 19439326 · Received May 31, 2024

    Report

    Report Number
    2518422-2024-33231
    Event Type
    Injury
    Date Received
    May 31, 2024
    Date of Event
    October 12, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO NO DEVICE INFORMATION, THE POSSIBILITY OF RECALL Z NUMBERS WOULD BE ONE OF THE FOLLOWING: Z-1972-2021, Z-1973-2021 OR Z-1974-2021. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER.

    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 MANUFACTURER RECEIVED INFORMATION ALLEGING NOSE IRRITATION, DIZZINESS, HEADACHE, HYPERSENSITIVITY, KIDNEY DISEASE/TOXICITY AND LIVER DISEASE/TOXICITY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. 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
    308345 PHILIPS CPAP DEVICE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other