BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR PRO C-FLEX+BZD

    MDR report key: 24438526 · Received February 24, 2026

    Report

    Report Number
    2518422-2026-104233
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    January 24, 2024
    Report Date
    February 25, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959036635
    PMA / PMN Number
    K091319
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE CAPA PROCESS IDENTIFIED COMPLAINTS NOT BEING CREATED FOR QUALITY ISSUES FOUND DURING THIRD PARTY SERVICING. BASED ON A REVIEW OF RECORDS IMPACTED BY THE IDENTIFIED ISSUE, IT WAS DETERMINED THAT THIS RECORD NEEDED TO BE CORRECTED AND IS NOW BEING SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    A DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER IN RELATION TO THE VOLUNTARY FIELD SAFETY NOTICE AND RECALL NOTIFICATION INVOLVING THE SOUND ABATEMENT FOAM USED IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION, THE SERVICE CENTER PERFORMED A VISUAL INSPECTION AND OBSERVED EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON SUCCESSFULLY, AND AIRFLOW WAS VERIFIED. THE SERVICE CENTER WAS NOT ABLE TO CONFIRM THE CUSTOMER REPORTED ALLEGATION. HOWEVER, VISIBLE FOAM DEGRADATION WAS IDENTIFIED, AND THE DEVICE WAS SCRAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499129 REMSTAR PRO C-FLEX+BZD VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. LA451HS 00606959036635

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown