BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 16204768 · Received January 19, 2023

    Report

    Report Number
    2518422-2023-02111
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    January 14, 2023
    Report Date
    July 4, 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 PREVIOUSLY 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 CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED VISUALIZATION OF PARTICLES. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. DESPITE OF MULTIPLE ATTEMPTS THE DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE PREVIOUS REPORT MDR 2518422-2023-02111-1 WAS SUBMITTED INADVERTENTLY. PLEASE CONSIDER THE INITIAL REPORT MDR 2518422-2023-02111.

    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. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR INVESTIGATION. EXTERNAL EXAMINATION OF THE UNIT FOUND A SCRATCHED LCD SCREEN AND DAMAGE TO THE BOTTOM ENCLOSURE. INTERNAL EXAMINATION FOUND VISIBLE FOAM PARTICLES INSIDE THE BLOWER KIT. NO OTHER CONTAMINATION WAS OBSERVED IN THE DEVICE. THE DEVICE WAS POWERED ON AND IS FUNCTIONAL. THE DEVICE'S DOWNLOADED EVENT LOG WAS REVIEWED BY THE THIRD PARTY SERVICE CENTER AND 0 ERRORS WERE LOGGED. THE MANUFACTURER CONFIRMED THE THIRD PARTY SERVICE CENTER FOUND EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129853 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown