BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS CPAP DEVICE

    MDR report key: 19274443 · Received May 8, 2024

    Report

    Report Number
    2518422-2024-26483
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    February 19, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    Z-1974-2021 - BZD K131982 Z-1972-2021 - MNS Z-1973-2021 - MNS DREAMSTATION ASV, ST, AVAPS . DUE TO THE MANUFACTURER NOT RECEIVING THE DEVICE INFORMATION, THE FOLLOWING ARE POSSIBLE RECALL Z NUMBERS : Z-1972-2021 . Z-1974-2021 . Z-1973-2021. H3 OTHER TEXT : DEVICE NOT RETURNED TO 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 LUNG DISEASE. MEDICAL INTERVENTION WAS NOT SPECIFIED. 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
    483117 PHILIPS CPAP DEVICE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other