BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A40 PRO

    MDR report key: 22042372 · Received May 19, 2025

    Report

    Report Number
    2518422-2025-045018
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    June 19, 2024
    Report Date
    May 19, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00606959059405
    PMA / PMN Number
    K121623
    Removal / Correction Number
    Z-1813-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIPAP A40 PRO (CAX3100S12) IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40 AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40, 510K 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 VENTILATOR WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY (PIL) FOR EVALUATION AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED PIL PERFORMED TESTING IN ACCORDANCE WITH ER 2251830 PART 002 VER 01 AND THE RESULTS MEET THE CRITERIA THAT NO FURTHER INVESTIGATION IS REQUIRED. E-20 ERROR WAS GENERATED DUE TO A DEFECTIVE EEPROM. THE DEVICE HAS BEEN SCRAPPED. PRIOR TO IDENTIFYING THE ISSUE DESCRIBED IN FSN 2023-CC-SRC-039, COMPLAINTS ASSOCIATED WITH THE ISSUE DID NOT MEET REQUIREMENTS FOR VIGILANCE REPORTING AS A REPORTABLE INCIDENT. AS PART OF THE HHE PROCESS, A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH THE ISSUE DESCRIBED IN FSN 2023-CC-SRC-039 WAS NECESSARY TO REASSESS REPORTABILITY. UPON THIS FURTHER ASSESSMENT, THESE COMPLAINTS ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132476 BIPAP A40 PRO VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. CAX3100S12 00606959059405

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown