BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP, ES

    MDR report key: 18037119 · Received October 31, 2023

    Report

    Report Number
    2518422-2023-28215
    Event Type
    Malfunction
    Date Received
    October 31, 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
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : ANALYSIS BY THIRD-PARTY.

    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. 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 THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND HAS NO VISUALIZATION OF FOAM PARTICLES. IN ADDITION TO ABOVE FINDINGS, THE POWER CONNECTOR OF THE UNIT IS CORRODED, CANNOT BE POWERED ON AND THE DEVICE WAS VERIFIED THAT THE POWER SOURCE WAS NOT CONNECTED. 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
    2222952 DREAMSTATION AUTO CPAP, ES VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. ESX500S15

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown