BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A40 PRO

    MDR report key: 20313260 · Received September 26, 2024

    Report

    Report Number
    2518422-2024-101100
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    September 11, 2024
    Report Date
    July 28, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00606959059092
    PMA / PMN Number
    K121623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION IS BEING SENT TO REPORT THIS AS A DUPLICATE REPORT. THIS COMPLAINT HAS BEEN FILED UNDER 2518422-2024-100061. ALL REPORTING WILL BE DONE UNDER 2518422-2024-100061. THIS IS A DUPLICATE REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR ALARMED AND WAS NOT FUNCTIONING. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A 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, 501K NUMBER: K121623.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1433868 BIPAP A40 PRO VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. NDX3100S19 00606959059092

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown