BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR PLUS C-FLEX

    MDR report key: 23960584 · Received January 5, 2026

    Report

    Report Number
    2518422-2026-000324
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    December 28, 2025
    Report Date
    March 19, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959015630
    PMA / PMN Number
    K091319
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP IS NECESSARY AS THE 510K UNDER REPORT INFORMATION SHOULD BE K091319 FOR REMSTAR PLUS C-FLEX 50 SERIES DEVICE AND DEVICE EVALUATED BY 3RD PARTY SHOULD BE YES.

    Description of Event or Problem · 0

    A REMSTAR PLUS C-FLEX DEVICE WAS RETURNED TO THE 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. THERE WAS NO INITIAL ALLEGED COMPLAINT FOUND. DURING EVALUATION, FOAM PARTICLES WERE NOTED INSIDE THE BLOWER KIT AND A BLFM-BLOWER FOAM DEGRADATION WAS FOUND. IN ADDITION, THE DEVICE HAD DUST CONTAMINATION AND DISPLAYED ERROR CODES E062 (ERR_STUCK_RAMP_KEY), E065 (ERR_STUCK_ENCODER_A), E066 (ERR_STUCK_ENCODER_B), E100 (ERR_HUMID_NO_HEAT). THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED. THIS EVENT IS REPORTABLE UNDER FDA 21 CFR PART 803 AS IT MEETS THE CRITERIA FOR A SERIOUS INJURY AND/OR PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19687 REMSTAR PLUS C-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 00606959015630

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown