BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTO A-FLEX

    MDR report key: 22666730 · Received July 30, 2025

    Report

    Report Number
    2518422-2025-108419
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    July 17, 2025
    Report Date
    August 1, 2025
    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
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BOX E HAS BEEN CORRECTED IN THE CURRENT REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED 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 REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. DURING EVALUATION OF THE DEVICE AT A THIRD-PARTY SERVICE CENTER, DAMAGED FOAM WAS FOUND INSIDE THE BLOWER KIT. ERROR CODES AND DUST/DIRT CONTAMINATION WAS OBSERVED. NO OTHER DEVICE PROBLEMS WERE FOUND. THE DEVICE WAS SCRAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50063 REMSTAR AUTO A-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. FR565S 00606959030725

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown