BEUDAMED
    FDA Adverse Event Death Summary report: N

    ICS INFINITY CENTRAL STATION

    MDR report key: 5066836 · Received September 10, 2015

    Report

    Report Number
    1220063-2015-00026
    Event Type
    Death
    Date Received
    September 10, 2015
    Date of Event
    August 30, 2015
    Report Date
    March 14, 2016
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K061379
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE ADDITIONAL ICS AND IACS LOGS WERE RECEIVED AND ANALYZED. THE ICS LOGS INDICATE AT THE TIME OF EVENT A NUMBER OF "ALARM SILENCE TIMER RESET" NOTIFICATIONS WERE ISSUED, INDICATING AN ACTIVE ALARM AT THE ICS WAS ACKNOWLEDGED BY THE USER. THE EVENT LOGS OF THE M540 INDICATE SEVERAL "SPO2 LOW PERFUSION" MESSAGES AS WELL AS "NIBP MEASUREMENT TIMEOUT" BUT NO ECG RELATED ALARMS OR EVENTS AT THE CITED TIME OF EVENT WHICH WAS REPORTED TO BE AROUND 3:30 PM ON (B)(6) 2015. THE REASON THAT AN ASYSTOLE WAS NOT DETECTED BY THE M540 AND THE ICS IS THAT THE M540 LOGS SHOW ON (B)(6) AT 22:23:41 THAT PACER DETECTION WAS TURNED OFF. SCREEN SHOTS ON THE M540 ALSO SHOW THAT THE USER DISABLED PACER DETECTION AT THIS MENTIONED TIME. AS A RESULT, THE M540 COULD NOT DETECT AN ASYSTOLE ON THE PACED PATIENT, AND THIS HAS BEEN DETERMINED TO BE THE ROOT CAUSE. THE IFU FOR THE INFINITY ACUTE CARE SYSTEM - INFINITY M540 SW VG4.N INDICATES ON PAGE 145: "MAKE SURE PACER DETECTION IS DEACTIVATED FOR PATIENTS WITHOUT PACEMAKERS. MAKE SURE IT IS ACTIVATED FOR PATIENTS WITH PACEMAKERS. DEACTIVATING PACEMAKER DETECTION FOR PACED PATIENTS MAY RESULT IN PACEMAKER PULSES BEING COUNTED AS REGULAR QRS COMPLEXES, WHICH COULD PREVENT AN ASYSTOLE ALARM FROM BEING DETECTED." THE DEVICE FUNCTIONED AS INTENDED.

    Additional Manufacturer Narrative · 1

    SCREENSHOTS AND PATIENT STATUS REPORT FROM THE INFINITY CENTRAL STATION AND THE ERROR LOG OF THE IACS M540 WERE PROVIDED FOR THE INVESTIGATION. THE ICS HARD DRIVE WHICH CONTAINS THE ICS LOGS WAS REQUESTED BY DRAEGER, BUT WAS NOT MADE AVAILABLE BY THE CUSTOMER. ALARM HISTORY LOG FILES WERE ALSO NOT AVAILABLE AS THE PATIENT HAD BEEN DISCHARGED. THE IACS IS THE PRIMARY PATIENT MONITOR. WHEN THE IACS ISSUES AN ALARM, IT WILL BE ADDITIONALLY DISPLAYED VISUALLY AND AUDIBLY AT THE ICS. WHEN THE IACS ISSUES A LOW GRADE ALARM, THEY WILL BE DISPLAYED AND HEARD UNTIL THE EVENT CEASES. IN THIS CASE THE IACS AUDIBLE ALARM VOLUME HAS BEEN TURNED OFF. NONETHELESS, A VISUAL ALARM ON THE IACS WILL INDICATE THE ALARM SITUATION. FROM THE AVAILABLE SCREENSHOTS AND PATIENT STATUS REPORT IT WAS CONCLUDED THAT THE ICS RECEIVED A FEW LIMIT ALARMS AND ONE ARRHYTHMIA EVENT. THE PATIENT STATUS REPORT SHOWS THAT THE LAST EVENT STORED AT THE ICS WAS THE ARRHYTHMIA ALARM: ¿ARR PAUSE¿ AT 15:23:58 ON (B)(6) 2015. THIS ALARM CAN BE CONFIGURED AS MEDIUM (NEEDS TO BE ACKNOWLEDGED BY THE USER) OR LOW (NO USER ACKNOWLEDGEMENT NEEDED, ONE-SHOT 2 SECOND AUDIBLE AND VISUAL ALARM) AND WAS CONFIGURED AT LOW BY THE USER. THE PROVIDED INFORMATION INDICATES THAT ALARMS WERE GIVEN BY THE ICS. AS THE ICS LOG FILES AND HARD DRIVES HAVE NOT BEEN MADE AVAILABLE BY THE USER A FURTHER ANALYSIS WAS NOT POSSIBLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TERMINALLY ILL PATIENT EXPIRED BUT THE ICS DID NOT ALARM. THE USER REPORTED THAT THEY WENT TO THE ROOM TO CHECK ON THE PATIENT AND FOUND THAT THE PATIENT HAD EXPIRED. THE AUDIBLE ALARM VOLUME AT THE BEDSIDE IACS M540 HAD REPORTEDLY BEEN TURNED OFF BECAUSE THE PATIENT'S FAMILY WAS IN THE ROOM. THE PATIENT WAS DISCHARGED FROM THE BEDSIDE MONITOR BEFORE LOGS COULD BE DOWNLOADED AND THE BEDSIDE MONITOR WAS REPORTEDLY SUBSEQUENTLY USED ON A NEW PATIENT. A TSR WAS DISPATCHED TO GATHER AVAILABLE LOGS AND DATA. (B)(4).

    Description of Event or Problem · 1

    PLEASE SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598774 ICS INFINITY CENTRAL STATION PHYSIOLOGICAL MONITORING SYSTEMS CBK DRAEGER MEDICAL SYSTEMS, INC UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death