BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A40 PRO

    MDR report key: 20157400 · Received September 6, 2024

    Report

    Report Number
    2518422-2024-56938
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    April 4, 2024
    Report Date
    November 11, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00606959059405
    PMA / PMN Number
    K121623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED RECEIVING INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS EVALUATED BY THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY (PIL) AND FOUND THE DEVICE FUNCTIONED AS DESIGNED AND OPERATED WITHOUT ISSUE OR ERROR CODES. THE BIPAP A40 PRO CAX3100S12 IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40 AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40, K121623.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS YET TO BE EVALUATED BY THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THE BIPAP A40 PRO CAX3100S12 IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40 AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40, K121623.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2046135 BIPAP A40 PRO VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. CAX3100S12 00606959059405

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown