BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A40 PRO

    MDR report key: 18712560 · Received February 15, 2024

    Report

    Report Number
    2518422-2024-07632
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    October 19, 2023
    Report Date
    July 18, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00606959059412
    PMA / PMN Number
    K121623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED RECEIVED INFORMATION ALLEGING THAT A VENTILATOR INOPERATIVE CONDITION OCCURRED ON A BIPAP A40 PRO DEVICE. IN ADDITION, PRESSURE ISSUES WERE ALLEGED. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED. THE DEVICE WAS EVALUATED BY THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY (PIL) AND NOTED THE VENTILATOR INOPERATIVE ALARMS DID SHOW IN THE ERROR LOG. THE OXYGEN SENSOR IN THE UNIT IS READING HIGH AT AMBIENT AIR CONDITIONS. PRIOR TO IDENTIFYING THE ISSUE DESCRIBED IN FSN 2023-CC-SRC-039, COMPLAINTS ASSOCIATED WITH THE ISSUE DID NOT MEET REQUIREMENTS FOR VIGILANCE REPORTING AS A REPORTABLE INCIDENT. AS PART OF THE HHE PROCESS, A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH THE ISSUE DESCRIBED IN FSN 2023-CC-SRC-039 WAS NECESSARY TO REASSESS REPORTABILITY. UPON THIS FURTHER ASSESSMENT, THESE COMPLAINTS ARE BEING REPORTED. THE BIPAP A40 PRO (CAX3100T12) 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 THAT A VENTILATOR INOPERATIVE CONDITION OCCURRED ON A BIPAP A40 DEVICE. IN ADDITION, PRESSURE ISSUES WERE ALLEGED. THERE WAS NO PATIENT HARM OR SERIOUS 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 ((B)(6)) 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
    542284 BIPAP A40 PRO VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. CAX3100T12 00606959059412

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown