BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A40 PRO

    MDR report key: 18841305 · Received March 5, 2024

    Report

    Report Number
    2518422-2024-11798
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Date of Event
    February 26, 2024
    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 BIPAP A40 PRO ((B)(6)) 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 WAS REPLACED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE DEVICE WAS SCRAPPED AND REPLACED BY A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583592 BIPAP A40 PRO VENTILATOR,CONTINUOUS,MINIMAL VENTILATOR SUPPORT, FACILITY USE MNT RESPIRONICS, INC. GBX3100S19 00606959055063

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown