BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS CPAP

    MDR report key: 20513145 · Received October 23, 2024

    Report

    Report Number
    2518422-2024-64845
    Event Type
    Injury
    Date Received
    October 23, 2024
    Date of Event
    October 9, 2023
    Report Date
    October 23, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    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 EYE IRRITATION, SKIN IRRITATION, RESPIRATORY TRACT IRRITATION, DIZZINESS AND/OR HEADACHE, HYPER SENSITIVITY, ASTHMA (NEW OR WORSENING)INFLAMMATORY RESPONSE, OTHER, ACUTE RESPIRATORY DISTRESS SYSTEM (ARDS), PLEURAL EFFUSION, REACTIVE AIRWAY DISEASE (RAD), RESPIRATORY FAILURE, SEVERE EAR, NOSE, THROAT INFLAMMATION, & RESPIRATORY ISSUES (BREATHING PROBLEMS). NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTIONS WERE REPORTED. 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
    319986 PHILIPS CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other