BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A40 PRO

    MDR report key: 19466195 · Received June 5, 2024

    Report

    Report Number
    2518422-2024-34151
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    May 31, 2024
    Report Date
    June 5, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00606959055148
    PMA / PMN Number
    K121623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIPAP A40 PRO ITX3100S21 IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40 R1111177 AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40 PRO 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 MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815197 BIPAP A40 PRO VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNT RESPIRONICS, INC. ITX3100S21 00606959055148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown