BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K091319

    MDR report key: 24027214 · Received January 9, 2026

    Report

    Report Number
    2518422-2026-001372
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Date of Event
    January 4, 2026
    Report Date
    January 9, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005013
    PMA / PMN Number
    K091319
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    505

    Narratives

    Description of Event or Problem · 0

    A REMSTAR AUTO A-FLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER AS PART OF THE UNO RECALL PROCESS WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES INSIDE THE BLOWER KIT. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO FOUND DUST FAIL CONTAMINATION AND ERROR CODES E019 (ERR_WDOG_TEST), E053 (ERR_COMP_LOG_SEM_TIMEOUT), E062(ERR_STUCK_RAMP_KEY), E063(ERR_STUCK_KNOB_KEY) AND E066(ERR_STUCK_ENCODER_B). THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92574 K091319 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS550S 00606959005013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown