BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 17731088 · Received September 12, 2023

    Report

    Report Number
    2518422-2023-22483
    Event Type
    Malfunction
    Date Received
    September 12, 2023
    Date of Event
    July 21, 2021
    Report Date
    June 11, 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 PATIENT STATED, "HE EXPERIENCED HEALTH RELATED PROBLEMS DURING USE OF HIS UNIT, A DREAMSTATION. HE EXPERIENCED CHEST DISCOMFORT, DRY THROAT, DRY COUGH, SINUSES PLUGGED UP. HE FEELS THIS RESULTED FROM USE OF THE MACHINE". THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTRE. THERE WAS THREE ZERO CODE FOUND. THE THIRD-PARTY SERVICE CENTRE CONCLUDES THAT THEY COULDN'T CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS NO VISIBLE FOAM DEGRADATION AND UNIT WAS SCRAPPED. IN BOX H: EVALUATION METHOD CODE GRID, EVALUATION RESULTS CODE GRID, COMPONENT CODE GRID, CONCLUSION CODE GRID HAS BEEN UPDATED

    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 PATIENT STATED, "HE EXPERIENCED HEALTH RELATED PROBLEMS DURING USE OF HIS UNIT, A DREAMSTATION. HE EXPERIENCED CHEST DISCOMFORT, DRY THROAT, DRY COUGH, SINUSES PLUGGED UP. HE FEELS THIS RESULTED FROM USE OF THE MACHINE". THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE PATIENT STATED, "HE DISCUSSED WITH HIS HEALTHCARE PROVIDER AND WILL NEED TO SEE AN EAR, NOSE, AND THROAT SPECIALIST". NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER. THE UNIT FAILED FINAL TEST THERAPY (UNCOMP FLOW). UNIT NOT NEEDED FOR INTERNAL STOCK. UNIT SCRAPPED PER FC: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173385 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male