BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A40 PRO, EE

    MDR report key: 19213163 · Received April 30, 2024

    Report

    Report Number
    2518422-2024-23792
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    December 22, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00606959059139
    PMA / PMN Number
    K121623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIPAP A40 PRO (EEX3100S19) IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40 (1111169) AND 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 BEEN RETURNED TO THE MANUFACTURER, BUT EVALUATION HAS NOT YET BEGUN. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137622 BIPAP A40 PRO, EE VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT MNT RESPIRONICS, INC. EEX3100S19 00606959059139

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown