BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAM STATION AUTO-CPAP

    MDR report key: 18131696 · Received November 14, 2023

    Report

    Report Number
    2518422-2023-30003
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    April 22, 2021
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION.

    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 VOLUNTARY MEDWATCH (MW 5102326). THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO HEADACHES. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THE PATIENT REQUIRED NO MEDICAL INTERVENTION. DESPITE OF MULTIPLE ATTEMPTS THE DEVICE HAS NOT YET 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
    1916598 DREAM STATION AUTO-CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500H1IC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown