BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 21077791 · Received January 6, 2025

    Report

    Report Number
    2518422-2025-000232
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    May 11, 2023
    Report Date
    June 19, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959025646
    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

    UPON REVIEW, IT WAS DETERMINED THIS REPORT IS A DUPLICATE OF MFR 2518422-2025-000229. ALL REPORTING WILL BE COMPLETED ON MFR 2518422-2025-000229. PLEASE DISREGARD MFR 2518422-2025-000232.

    Description of Event or Problem · 0

    THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION 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 DEVICE WAS NOT IN PATIENT USE. THE INTERNAL PART OF THE DEVICE WAS INSPECTED VISUALLY AND FOUND EVIDENCE OF VISIBLE FOAM DEGRADATION. LASTLY, THE DEVICE HAS BEEN SCRAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136627 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500T11C 00606959025646

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown