BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO BIPAP

    MDR report key: 21512595 · Received March 4, 2025

    Report

    Report Number
    2518422-2025-025253
    Event Type
    Malfunction
    Date Received
    March 4, 2025
    Date of Event
    May 24, 2022
    Report Date
    March 4, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959429772
    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 MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED VISUALIZATION OF PARTICLES IN DEVICE. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THE TECHNICIAN CONFIRMED NO PARTICLES IN THE AIR PATH DURING THE DEVICE EVALUATION. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY COULD CONFIRM THE CUSTOMER'S ALLEGATION. DURING THE EVALUATION, SECONDARY FINDINGS DAMAGED UI PANEL, SCRATCH, DAMAGED TOP ENCLOSURE, CRACK AT AMBIENCE LIGHT, REPLACED WAS OBSERVED. THE DEVICE WAS CORRECTED. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696570 DREAMSTATION AUTO BIPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. UDSX700S11F 00606959429772

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown