BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIPAP A40 SYSTEM SILVER, JP

    MDR report key: 21632575 · Received March 18, 2025

    Report

    Report Number
    2518422-2025-103124
    Event Type
    Death
    Date Received
    March 18, 2025
    Date of Event
    March 10, 2025
    Report Date
    May 5, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00606959412729
    PMA / PMN Number
    K121623
    Removal / Correction Number
    Z-1813-2024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER AND EVALUATION COMPLETED WITH THE FOLLOWING RESULTS: A VENTILATOR INOPERATIVE ERROR CODE WAS CONFIRMED TO BE PRESENT IN THE DOWNLOAD ERROR LOG INDICATING THE DEVICE WAS UNABLE TO WRITE TO THE VENT LOG. EVALUATION CONFIRMED THE ALLEGED VENTILATOR INOPERATIVE CONDITION. THE MAIN PRINTED CIRCUIT ASSEMBLY WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE PASSED FINAL TESTING AND WAS CONFIRMED TO BE OPERATING PROPERLY.

    Additional Manufacturer Narrative · 0

    THE BIPAP A40 PRO (UPDATE MATERIAL # FROM RA) 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

    ON 13 MARCH 2025, THE MANUFACTURER RECEIVED INFORMATION INDICATING A PATIENT USING A BIPAP A40 VERSION 3 DEVICE HAD DIED. THE HEALTH FACILITY CONTACTED PHILIPS' CALL CENTER REQUESTING TO RETURN OF THE SUBJECT DEVICE. THE PHILIPS SALES REPRESENTATIVE LEARNED OF THE PATIENT'S DEATH WHEN THEY WENT TO THE FACILITY TO RETRIEVE THE DEVICE AS REQUESTED. IT WAS REPORTED A VENTILATOR INOPERATIVE ALARM HAD OCCURRED ON THE DEVICE AND THE VENTILATOR HAD STOPPED OPERATING. THE MEDICAL STAFF RESPONDED TO THE PATIENT EMERGENCY WITH MANUAL RESUSCITATION OF THE PATIENT USING AN AMBU BAG. HOWEVER, THERE WAS NO CHANGE IN THE PATIENT'S CONDITION. THE PATIENT WAS TRANSFERRED TO A HOSPITAL BY AMBULANCE WHERE THEY DIED THAT NIGHT. THE CAUSE OF DEATH REMAINS UNKNOWN TO THE MANUFACTURER AT THIS TIME. THIS ISSUE HAS BEEN IDENTIFIED UNDER THE FSN 2023-CC-SRC-039.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454096 BIPAP A40 SYSTEM SILVER, JP VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. R1111177 00606959412729

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Death