BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR PRO C-FLEX +

    MDR report key: 23536459 · Received November 12, 2025

    Report

    Report Number
    2518422-2025-111743
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    November 14, 2025
    Report Date
    November 14, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K091319
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED ON THIS DEVICE IN MDR 2518422-2025-111743. THIS REPORT WAS SUBMITTED AS A CORRECTION OF THE PREVIOUSLY SUBMITTED REPORT WHICH REPORTED THE REPORTER COUNTRY AS ROMANIA. THE CORRECT COUNTRY IS SLOVAKIA.

    Description of Event or Problem · 0

    A REMSTAR PRO C-FLEX + DEVICE WAS RETURNED TO THE SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THERE WAS NO INITIAL ALLEGED COMPLAINT FOUND. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES. ADDITIONALLY, DUST AND DIRT CONTAMINATION WAS OBSERVED BY THE TECHNICIAN DURING EVALUATION OF THE DEVICE. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2593838 REMSTAR PRO C-FLEX + VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 451P

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown