BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A40 PRO, IT

    MDR report key: 22978517 · Received September 5, 2025

    Report

    Report Number
    2518422-2025-109732
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    September 3, 2025
    Report Date
    September 5, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00606959055148
    PMA / PMN Number
    K121623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING NOT OPERATIVE. THERE WAS NO HARM OR INJURY REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THE BIPAP A40 PRO IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40 AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40 PRO, 501K NUMBER: K121623.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305603 BIPAP A40 PRO, IT VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. ITX3100S21 00606959055148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown