BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTO A-FLEX

    MDR report key: 22680872 · Received July 31, 2025

    Report

    Report Number
    2518422-2025-108538
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    July 23, 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

    ON PREVIOUSLY SUBMITTED REPORT, REPORTER COUNTRY IN BOX E WAS INCORRECT. SECTION TYPE OF REPORTER COUNTRY IN BOX E HAS BEEN UPDATED/CORRECTED IN THIS REPORT.

    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
    165592 REMSTAR AUTO A-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. FR565S 00606959030725

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown