BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO BIPAP

    MDR report key: 13485700 · Received February 8, 2022

    Report

    Report Number
    2518422-2022-03706
    Event Type
    Malfunction
    Date Received
    February 8, 2022
    Date of Event
    January 10, 2022
    Report Date
    January 1, 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
    OTHER
    Health Professional
    N

    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 VISUALIZATION OF PARTICLES RELATED TO A BIPAP 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. SECTION H6 UPDATED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON DEC 023, 2023 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, VISUALIZATION OF PARTICLES RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE THIRD PARTY SERVICE CENTER FOR FURTHER EVALUATION. THE DEVICE WAS EVALUATED. THERE WAS NO MENTION OF VISUAL FINDINGS TO THE EXTERNAL PART OF THE DEVICE. THE INTERNAL ASPECT OF THE DEVICE WAS INSPECTED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED. THERE WERE NO ERRORS FOUND. THE THIRD PARTY SERVICE CENTER CONCLUDES THAT THEY COULD NOT CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS NO VISIBLE FOAM DEGRADATION. DEVICE WAS SCRAPPED. SECTIONS D8, D9, H2, H3 AND H6 HAS BEEN UPDATED IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES RELATED TO THE BIPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT 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
    1849244 DREAMSTATION AUTO BIPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX700T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown