BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A40 PRO

    MDR report key: 19943275 · Received August 8, 2024

    Report

    Report Number
    2518422-2024-100025
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    August 1, 2024
    Report Date
    July 15, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00606959059412
    PMA / PMN Number
    K121623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIPAP A40 PRO (CAX3100T12) IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40 (1111169) AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40, 501K NUMBER: K121623.

    Additional Manufacturer Narrative · 0

    CORRECTION: THE MANUFACTURER RECEIVED INFORMATION ALLEGING A 'HIGH INTERNAL O2"ALARM HAD OCCURRED CAUSING A VENTILATOR INOPERATIVE CONDITION TO OCCUR ON THE DEVICE. 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 UDI IN SECTION D4 WAS PREVIOUSLY REPORTED IN THE INCORRECT FORMAT. THE UDI INFORMATION HAS BEEN UPDATED TO THE CORRECT FORMAT.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A 'HIGH INTERNAL O2"ALARM HAD OCCURRED CAUSING A VENTILATOR INOPERATIVE CONDITION TO OCCUR ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THE PHILIPS PRODUCT INVESTIGATION LAB (PIL) IS ABLE TO CONFIRM THE COMPLAINT OF THE A40 PRO, VISUAL INSPECTION FOUND NO ISSUES. PIL PERFORMED TESTING IN ACCORDANCE WITH ER 2251830 PART 001 VER 01 AND THE RESULTS MEET THE CRITERIA THAT NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A 'HIGH INTERNAL O2"ALARM HAD OCCURRED CAUSING A VENTILATOR INOPERATIVE CONDITION TO OCCUR ON THE DEVICE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2398102 BIPAP A40 PRO VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. CAX3100T12 00606959059412

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown