BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP PRO BIFLEX

    MDR report key: 23682639 · Received December 1, 2025

    Report

    Report Number
    2518422-2025-112177
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    December 5, 2025
    Report Date
    December 8, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959069343
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED ON THIS DEVICE IN MDR 2518422-2025-112177. THIS REPORT WAS SUBMITTED AS A CORRECTION REPORT OF THE PREVIOUSLY SUBMITTED REPORT. COUNTRY OF OCCURRENCE HAS BEEN UPDATED FROM "CYPRUS" TO GREECE" AND BOX E: INITIAL REPORTER DETAILS HAVE BEEN UPDATED.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A BIPAP PRO BIFLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF FOAM PARTICLES WERE FOUND. THE DEVICE HAS BEEN SCRAPPED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2219721 BIPAP PRO BIFLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. IN661S 00606959069343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown