BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY ACUTE CARE SYSTEM (M540)

    MDR report key: 5984627 · Received September 28, 2016

    Report

    Report Number
    1220063-2016-00030
    Event Type
    Malfunction
    Date Received
    September 28, 2016
    Date of Event
    August 22, 2016
    Report Date
    November 2, 2016
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K113798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IACS LOGS FROM THE EVENT WERE REVIEWED BY ENGINEERING. A VIDEO CAPTURING THE ISSUE WAS PROVIDED. AFTER REVIEWING THE PROVIDED VIDEO AND CORRESPONDING LOGS, IT COULD BE CONFIRMED THAT THE PULSE TONES AND AUDIBLE ALARMS WERE NOT WORKING DURING THE EVENT AFTER BEING IN STANDBY. THE NO AUDIO ISSUE AT BOTH THE COCKPIT AND M540 WAS REPRODUCED DURING THE INVESTIGATION. IT HAS BEEN DETERMINED THAT THERE IS A BUG IN THE MICROSOFT WINDOWS AUDIO SERVICE SUBSYSTEM THAT CAUSES A LOSS OF ALL AUDIO. A FIELD SAFETY CORRECTIVE ACTION HAS BEEN RELEASED TO CURRENT USERS OF IACS VG5 FOR A MANDATORY DOWNGRADE TO VG4. THE FIELD SAFETY CORRECTIVE ACTION RELEASED FOR THIS ISSUE IS NOT APPLICABLE FOR THE DEVICES IN THE US MARKET WHERE THE AFFECTED SOFTWARE VERSION IS NOT USED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS STARTED BUT HAS NOT YET BEEN CONCLUDED. THE INVESTIGATION RESULT WILL BE REPORTED IN THE FOLLOW UP REPORT.

    Description of Event or Problem · 1

    PLEASE REFER TO THE INITIAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AFTER INSTALLATION 9:30PM (B)(6), ALL FUNCTIONS OF IACS ARE FINE, HOWEVER, THE NEXT MORNING THE CLINICAL SPECIALIST NOTICED THAT WHILST THE M540 WAS ACOUSTICALLY ALARMING (WHICH IT SHOULDN'T IN AN IACS CONFIGURATION), AND THE COCKPIT WAS NOT ANNUNCIATING AN ALARM. FURTHER COMMUNICATION WITH CUSTOMER INDICATED THE M540 INTERMITTENTLY HAD NO AUDIBLE ALARM. THERE IS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634650 INFINITY ACUTE CARE SYSTEM (M540) PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT CBK DRAEGER MEDICAL SYSTEMS, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1