BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS DREAM STATION 2

    MDR report key: 18938199 · Received March 19, 2024

    Report

    Report Number
    2518422-2024-13017
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Date of Event
    February 1, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED VIA A VOLUNTARY MEDWATCH (VMW 5151123) IN REFERENCE TO THE USER OF A DREAMSTATION 2 DEVICE ALLEGING BLACK SPECS IN THE WATER CHAMBER. THERE IS NO ALLEGATION OF PATIENT HARM OR SERIOUS INJURY. THERE IS NO CLINICAL INFORMATION OR MEDICAL INTERVENTION SPECIFIED. 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
    476804 PHILIPS DREAM STATION 2 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown