BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR PRO C-FLEX

    MDR report key: 23936785 · Received December 31, 2025

    Report

    Report Number
    2518422-2025-113477
    Event Type
    Malfunction
    Date Received
    December 31, 2025
    Date of Event
    December 20, 2025
    Report Date
    March 19, 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

    A FOLLOW-UP IS NECESSARY AS THE 510K UNDER REPORT INFORMATION SHOULD BE K091319 FOR REMSTAR PRO C-FLEX 50 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 AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF FOAM DEGRADATION/PARTICLES WAS FOUND INSIDE THE BLOWER KIT. THE DEVICE FOUND DUST CONTAMINATION, AND THE UNIT WAS FUNCTIONAL. ADDITIONALLY, THE DEVICE FOUND THE ERROR CODE, E065 (A ENCODER STUCK ERROR), E055 (THERAPY QUEUE FULL ERROR), AND E024 (MOTOR SPEED REVERSE ERROR). THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2570878 REMSTAR PRO C-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 00606959004986

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown