BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR PLUS C-FLEX

    MDR report key: 23955947 · Received January 5, 2026

    Report

    Report Number
    2518422-2026-000164
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    December 23, 2025
    Report Date
    March 19, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005846
    PMA / PMN Number
    K131982
    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

    A FOLLOW-UP IS NECESSARY AS THE 510K UNDER REPORT INFORMATION SHOULD BE K131982 FOR REMSTAR PLUS C-FLEX 60 SERIES DEVICE.

    Description of Event or Problem · 0

    A REMSTAR PRO C-FLEX+ DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER FOUND VISIBLE FOAM PARTICLES INSIDE THE BLOWER KIT. IN ADDITION, THE SERVICE CENTER FOUND ERROR CODES E055 ( ERR_THERAPY_QUEUE_FULL), E062 ( ERR_STUCK_RAMP_KEY) AS WELL AS E063 (ERR_STUCK_KNOB_KEY) AND DUST CONTAMINATION. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19184 REMSTAR PLUS C-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS460TS 00606959005846

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown