BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 12580465 · Received October 5, 2021

    Report

    Report Number
    2518422-2021-04843
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    August 4, 2021
    Report Date
    April 29, 2025
    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
    003

    Narratives

    Additional Manufacturer Narrative · 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 PREVIOUSLY RECEIVED INFORMATION ALLEGING ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. SECTION B5 HAS BEEN CORRECTED AND SHOULD BE REPORTED AS: THE MANUFACTURER RECEIVED INFORMATION ALLEGING SHORTNESS OF BREATH, FOAM STUFF IN TANK RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF 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. CORRECTED INFORMATION WAS PROVIDED IN SECTION G1. SECTION H6 CORRECTED AND UPDATED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON APR 15, 2025 AND SECTION H11 SHOULD BE REPORTED AS: 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 SHORTNESS OF BREATH, FOAM STUFF IN TANK RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. ADDITIONAL INFORMATION WAS RECEIVED ABOUT THE ALLEGED VISUALIZATION OF PARTICLES. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.

    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
    1472890 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500T11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female