BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION CPAP PRO

    MDR report key: 21098931 · Received January 8, 2025

    Report

    Report Number
    2518422-2025-000515
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    August 10, 2021
    Report Date
    February 26, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959424586
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INITIALLY REPORTED MDR 2518422-2025-000515 AS A REPORTABLE EVENT. HOWEVER, UPON REVIEW, IT WAS OBSERVED THAT THERE WERE NO ALLEGATIONS OF FOAM PARTICLES, NO DEVICE MALFUNCTIONS AND THERE WAS NO REPORT OF SERIOUS INJURY OR HARM. THEREFORE, THIS EVENT IS NOW CONSIDERED NOT REPORTABLE.

    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 INFORMATION ALLEGING SEVERE IRRITATION IN AIRWAY PREVENTING HER FROM SLEEPING PROPERLY AT NIGHT AND MODULATING VOLUME OF NOISE FROM THE DEVICE. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE REQUESTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883869 DREAMSTATION CPAP PRO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. AUX400T15 00606959424586

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female