BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP W/HUMID/HT, DOM

    MDR report key: 17921028 · Received October 12, 2023

    Report

    Report Number
    2518422-2023-26385
    Event Type
    Malfunction
    Date Received
    October 12, 2023
    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

    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 PATIENT ALLEGES THAT THE DEVICE WILL NOT TURN ON OR WILL NOT FUNCTIONING. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. A DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE, THE MANUFACTURER VISUALLY INSPECTED THE DEVICE AND HAS VISUALIZATION OF FOAM PARTICLES. IN ADDITION TO ABOVE FINDINGS, THE PATIENT'S ALLEGATION OF THE DEVICE NOT FUNCTIONING WAS NOT CONFIRMED. THE DEVICE WAS ROUTED TO SCRAP. DEVICE NOT NEEDED FOR INTERNAL STOCK AND WILL BE SCRAPPED PER FC:(B)(4). 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
    1415100 DREAMSTATION AUTO CPAP W/HUMID/HT, DOM VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500T11

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown