BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR PRO C-FLEX+

    MDR report key: 21326638 · Received February 6, 2025

    Report

    Report Number
    2518422-2025-013019
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    March 18, 2022
    Report Date
    February 21, 2025
    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
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED ON THIS DEVICE IN MDR 2518422-2025-013019. THIS REPORT WAS SUBMITTED AS A DUPLICATE REPORT OF THE PREVIOUSLY SUBMITTED REPORT.

    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. THE PATIENT ALLEGED VISUALIZATION OF PARTICLES IN DEVICE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248108 REMSTAR PRO C-FLEX+ VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS450HS 00606959004986

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown