BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REP DREAMSTATION AUTO

    MDR report key: 21301253 · Received February 4, 2025

    Report

    Report Number
    2518422-2025-010679
    Event Type
    Malfunction
    Date Received
    February 4, 2025
    Date of Event
    June 18, 2024
    Report Date
    May 5, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959022485
    PMA / PMN Number
    K131982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED, AND SECTION H SHOULD BE REPORTED AS: THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTIONS WERE REPORTED. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTRE. DURING THE EVALUATION, THE TECHNICIAN CONFIRMED NO EVIDENCE OF FOAM DEGRADATION, NO PARTICLES IN THE AIR PATH AND SECONDARY FINDINGS WAS NOT OBSERVED. THERE WAS NO ERROR CODE FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY COULDN'T CONFIRM THE CUSTOMER'S ALLEGATION AND THE DEVICE WAS CORRECTED. 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. EVALUATION METHOD CODE GRID, EVALUATION RESULTS CODE GRID, COMPONENT CODE GRID AND CONCLUSION CODE GRID HAS BEEN UPDATED.

    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
    1134323 REP DREAMSTATION AUTO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. UDSX500S11F 00606959022485

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown