BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A40 PRO

    MDR report key: 20212309 · Received September 13, 2024

    Report

    Report Number
    2518422-2024-58543
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    April 18, 2024
    Report Date
    March 3, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00606959055063
    PMA / PMN Number
    K121623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    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 VENTILATOR WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY (PIL) FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS NOT DUPLICATED. THE DEVICE OPERATED AND ALARMED AS DESIGNED. THE BIPAP A40 PRO IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40, 501K NUMBER: 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 NOT BEEN RETURNED TO 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 IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40, 501K NUMBER: K121623.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111829 BIPAP A40 PRO VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. GBX3100S19 00606959055063

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown