BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION CPAP

    MDR report key: 12699155 · Received October 26, 2021

    Report

    Report Number
    2518422-2021-05695
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    September 15, 2021
    Report Date
    May 25, 2023
    Manufacturer
    RESPIRONICS,INC
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. IN INITIAL REPORTS SECTION B5 MENTIONED INCOMPLETE, CORRECT B5 SHOULD BE: 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 PREVIOUSLY RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES IN THE CHAMBER \ TUBING, DEVICE HAS NOT TURN ON FOR A FEW TIMES BEFORE THAN IT TURNS BACK ON, GET TO HOT BUT TO HOT TO TOUCH, THROAT IRRITATION, SINUS ISSUES, DEVICE WAS NOISY, DIFFICULTY BREATHING/SHORT OF BREATH RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. REPEATED ATTEMPTS TO HAVE THE DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. 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.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1596125 DREAMSTATION CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS,INC DSX200T11

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown