BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMWEAR

    MDR report key: 23235600 · Received October 7, 2025

    Report

    Report Number
    2518422-2025-110818
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    September 24, 2025
    Report Date
    April 22, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K140980
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED ON THIS DEVICE IN MDR 2518422-2025-110818. THIS REPORT WAS SUBMITTED AS A CORRECTION REPORT OF THE PREVIOUSLY SUBMITTED REPORT. EVALUATION RESULTS CODE GRID AND CONCLUSION CODE GRID HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED INFORMATION FROM A PHYSICIAN ALLEGING THEIR PATIENT IS EXPERIENCING POSSIBLE CONTACT DERMATITIS, SCALP IRRITATION, HAIR THINNING, SCABBING, AND REDNESS, WHICH ARE BELIEVED TO BE CAUSED BY THE MASK STRAP. THERE IS AN ALLEGATION OF PRODUCT MALFUNCTION, AND THE PATIENT HAS SOUGHT MEDICAL INTERVENTION. 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 PRODUCT ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED TO THE MANUFACTURER. 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 · 0

    THE MANUFACTURER RECEIVED INFORMATION FROM A PHYSICIAN ALLEGING THEIR PATIENT IS EXPERIENCING POSSIBLE CONTACT DERMATITIS, SCALP IRRITATION, HAIR THINNING, SCABBING, AND REDNESS, WHICH ARE BELIEVED TO BE CAUSED BY THE MASK STRAP. THERE IS AN ALLEGATION OF PRODUCT MALFUNCTION, AND THE PATIENT HAS SOUGHT MEDICAL INTERVENTION. THE INVESTIGATION IS ON-GOING AND THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A REPORT WILL BE FILED WITH ALL APPLICABLE REGULATORY AGENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116160 DREAMWEAR VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 1116710

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female