BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR PRO C-FLEX+, SYS ONE, 60 SRS,GER

    MDR report key: 21068413 · Received January 3, 2025

    Report

    Report Number
    2518422-2025-100014
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    December 19, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959069992
    PMA / PMN Number
    K113068
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE DREAMSTATION AUTO CPAP W/HUMID/HT, CAN DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER ABOUT THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY, AND THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION, THE SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND THE DEVISE HAD A MISSTORN CONTROL DIAL BUTTON AND EVIDENCE OF FOAM PARTICLES INSIDE THE ASSEMBLY. THE DEVICE WAS SCRAPPED PER CUSTOMER REQUEST. NO FURTHER INVESTIGATION CAN BE CARRIED OUT AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568519 REMSTAR PRO C-FLEX+, SYS ONE, 60 SRS,GER VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DE462S 00606959069992

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown