BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTO A-FLEX

    MDR report key: 22679821 · Received July 31, 2025

    Report

    Report Number
    2518422-2025-108507
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    July 18, 2025
    Report Date
    January 30, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959030725
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    IN PREVIOUSLY SUBMITTED REPORT, REPORT INFORMATION 510K NUMBER, OPERATOR OF DEVICE IN BOX D, OCCUPATION IN BOX E WAS INCORRECT. IN THIS REPORT, SECTION REPORT INFORMATION 510K NUMBER, 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, FOAM PARTICLES WERE VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2278131 REMSTAR AUTO A-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. FR565S 00606959030725

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown