BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR PRO C-FLEX+

    MDR report key: 23988707 · Received January 7, 2026

    Report

    Report Number
    2518422-2026-000731
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    December 28, 2025
    Report Date
    March 16, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959004986
    PMA / PMN Number
    K091319
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE PREVIOUS REPORT. IN PREVIOUS REPORT 510K NUMBER WAS WRONG. AS IT IS A 50S DEVICE THE 510K NUMBER SHOULD K091319. MANDATORY SECTION HAS BEEN UPDATED/CORRECTED.

    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. A REMSTAR PRO C-FLEX+ DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER THE DEVICE WAS VISUALLY INSPECTED AND EVIDENCE OF FOAM DEGRADATION WAS FOUND INSIDE THE BLOWER KIT. MOREOVER, THE DEVICE HAD DUST CONTAMINATION. ADDITIONALLY, THE DEVICE HAD DISPLAYED ERROR CODES E007 (ERR_SOFTWARE), E053 (ERR_COMP_LOG_SEM_TIMEOUT), E055 (ERR_THERAPY_QUEUE_FULL), E065 (ERR_STUCK_ENCODER_A) AND E066 (ERR_STUCK_ENCODER_B). IN ADDITION, THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50711 REMSTAR PRO C-FLEX+ VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS450HS 00606959004986

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown