BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR PRO C-FLEX+

    MDR report key: 22508352 · Received July 15, 2025

    Report

    Report Number
    2518422-2025-107486
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    June 26, 2025
    Report Date
    January 29, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959014077
    PMA / PMN Number
    K091319
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    IN PREVIOUSLY SUBMITTED REPORT, REPORT INFORMATION, OPERATOR OF DEVICE IN BOX D, OCCUPATION IN BOX E WAS INCORRECT. IN THIS REPORT, SECTION REPORT INFORMATION, OPERATOR OF DEVICE IN BOX D, OCCUPATION IN BOX E HAS BEEN UPDATED/CORRECTED.

    Description of Event or Problem · 0

    A DEVICE WAS RETURNED TO A THIRD-PARTY 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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED/SCRAPPED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, CONTAMINATION OF FOAM PARTICLES FOUND INSIDE THE BLOWER KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1740580 REMSTAR PRO C-FLEX+ VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. CA451HS 00606959014077

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown