BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REP DREAMSTATION AUTO

    MDR report key: 21628302 · Received March 18, 2025

    Report

    Report Number
    2518422-2025-036010
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    October 27, 2023
    Report Date
    June 18, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959063471
    PMA / PMN Number
    K131982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H IS BEING UPDATED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED INFORMATION ALLEGING VISUALIZATION OF PARTICLES. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTIONS WERE REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. IN THIS REPORT UPDATED AS- THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A DREAMSTATION AUTO CPAP DEVICE'S. THE PATIENT HAS ALLEGED VISUALIZATION OF PARTICLES. THERE WAS NO REPORT OF HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION OF THE DEVICE, CUSTOMER COMPLAINT WAS CONFIRMED. THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND FOAM PARTICLES. IN ADDITION, THE DEVICE WAS SCRAPPED. IN THIS REPORT, BOX D, H, B HAS BEEN UPDATED/CORRECTED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTIONS WERE REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689753 REP DREAMSTATION AUTO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500S11F 00606959063471

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown