BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION

    MDR report key: 17764761 · Received September 18, 2023

    Report

    Report Number
    2518422-2023-23375
    Event Type
    Injury
    Date Received
    September 18, 2023
    Date of Event
    August 28, 2023
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 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 ASTHMA, INFLAMMATORY RESPONSE, LUNG DISEASE, AND REDUCED CARDIO RESERVE. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. A CORRECTION WAS MADE TO BOX B: ADVERSE EVENT OR PRODUCT PROBLEM. DUE TO AN ERROR DURING INITIAL REPORTING THE BOX WAS CHANGED FROM BOTH TO ADVERSE EVENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    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 ASTHMA, INFLAMMATORY RESPONSE, LUNG DISEASE, AND REDUCED CARDIO RESERVE. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. 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
    1269092 DREAMSTATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS NORTH AMERICA LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other