BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTO A-FLEX

    MDR report key: 23544175 · Received November 13, 2025

    Report

    Report Number
    2518422-2025-111791
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    November 14, 2025
    Report Date
    November 24, 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
    FR
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED ON THIS DEVICE IN MDR 2518422-2025-111791. THIS REPORT WAS SUBMITTED AS A CORRECTION REPORT OF THE PREVIOUSLY SUBMITTED REPORT. THE REPORTER COUNTRY HAS BEEN UPDATED TO FRANCE.

    Description of Event or Problem · 0

    THIS NOTIFICATION WAS OPENED FOR REVIEW FOR INFORMATION RECEIVED THAT THE REMSTAR AUTO A-FLEX WAS RETURNED TO A THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM PARTICLES INSIDE THE ASSEMBLY. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND EVIDENCE OF VISIBLE FOAM PARTICLES INSIDE THE ASSEMBLY WAS FOUND. IN ADDITION, THE DEVICE HAD DUST/DIRT CONTAMINATION AND DISPLAYED ERROR CODES E065 (ERR_STUCK_ENCODER_A) AND E066 (ERR_STUCK_ENCODER_B). LASTLY, THE DEVICE WAS SCRAPPED AS PER CUSTOMER REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2119276 REMSTAR AUTO A-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 551P

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown