BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR SYSTEM ONE 60 SERIES

    MDR report key: 24466728 · Received February 27, 2026

    Report

    Report Number
    2518422-2026-006760
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Date of Event
    November 26, 2024
    Report Date
    February 27, 2026
    Manufacturer
    RESPIRATORY TECHNOLOGIES, INC.
    Product Code
    BZD
    UDI-DI
    00606959030299
    PMA / PMN Number
    K113068
    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

    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 SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND EVIDENCE OF FOAM DEGRADATION/PARTICLES WAS FOUND. ADDITIONALLY, THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530533 REMSTAR SYSTEM ONE 60 SERIES VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRATORY TECHNOLOGIES, INC. LA461HS 00606959030299

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown