BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 22050560 · Received May 20, 2025

    Report

    Report Number
    2518422-2025-045099
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    July 29, 2022
    Report Date
    November 10, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959051515
    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

    ¿THE MANUFACTURER PREVIOUSLY REPORTED ON THIS DEVICE IN MDR 2518422-2025-041205. THIS REPORT WAS SUBMITTED AS A DUPLICATE REPORT OF THE PREVIOUSLY SUBMITTED REPORT.¿

    Description of Event or Problem · 0

    A DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER 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. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF FOAM PARTICLES. AFTER THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER CORRECTED THE DEVICE AND ALSO DETERMINED THAT THE SECONDARY FINDINGS WERE OBSERVED. THERE WERE ONE ERROR LOGGED. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY COULD CONFIRM THE CUSTOMER'S ALLEGATION. IN ADDITION TO THE ABOVE FINDINGS, IT WAS ALSO DETERMINED THAT THE BOTTOM ENCLOSURE DAMAGE . IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2128965 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500H11C 00606959051515

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown