BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY ACUTE CARE SYSTEM (M540)

    MDR report key: 21762175 · Received April 3, 2025

    Report

    Report Number
    1220063-2025-00027
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 13, 2025
    Report Date
    September 2, 2025
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    MHX
    UDI-DI
    04049098054454
    PMA / PMN Number
    K113798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS STARTED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION.

    Additional Manufacturer Narrative · 0

    A DRAEGER TECHNICIAN WENT TO THE FACILITY TO RETRIEVE THE COCKPIT AND THE M540 LOGS FOR THE DATE AND TIME OF EVENT. THE LOG ANALYSIS CONFIRMED THE DISCONNECT, BUT THE EXACT ROOT CAUSE COULD NOT BE IDENTIFIED. THE ENTIRE IACS SYSTEM WAS REQUESTED WITH BOTH THE C500 AND THE M540 FOR ANALYSIS. THE IACS SYSTEM WAS CONNECTED TO THE DRAEGER INTERNAL NETWORK FOR TESTING AND NO OBSERVABLE DISCONNECT OCCURRED IN THE TWO MONTHS RUNNING AN ECG AND WAVEFORM SIMULATION. THE CUSTOMER WAS SENT A REPLACEMENT IACS SYSTEM WHICH WAS CONFIRMED TO BE WORKING ACCORDING TO MANUFACTURER'S SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INFINITY M540 MONITOR DISCONNECTED FROM THE INFINITY MEDICAL COCKPIT C500 DURING A PATIENT CARDIAC PROCEDURE AND THE M540 MONITOR WAS SWAPPED OUT AS A RESULT. ALTHOUGH AN INTERRUPTION IN PATIENT MONITORING OCCURRED, NO ADVERSE PATIENT IMPACT WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INFINITY M540 MONITOR DISCONNECTED FROM THE INFINITY MEDICAL COCKPIT C500 DURING A PATIENT CARDIAC PROCEDURE AND THE M540 MONITOR WAS SWAPPED OUT AS A RESULT. ALTHOUGH AN INTERRUPTION IN PATIENT MONITORING OCCURRED, NO ADVERSE PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731229 INFINITY ACUTE CARE SYSTEM (M540) PHYSIOLOGICAL MONITORING SYSTEMS MHX DRAEGER MEDICAL SYSTEMS, INC N/A N/A 04049098054454

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown