BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE MX700 PATIENT MONITOR

    MDR report key: 7182174 · Received January 11, 2018

    Report

    Report Number
    9610816-2018-00013
    Event Type
    Death
    Date Received
    January 11, 2018
    Date of Event
    January 4, 2018
    Report Date
    January 8, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K110622
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THERE WAS NO MALFUNCTION FOUND WITH THE DEVICE. ALARM LOG FILES FROM THE CENTRAL STATION (PIIC) WERE SUBMITTED TO PHILIPS AND WERE REVIEWED BY A PHILIPS SOFTWARE DEVELOPMENT ENGINEER (SDE). THE REVIEW OF THE PIIC LOG FILES PROVIDED BY SDE REVEALED THAT THE DEVICE HAD BEEN SILENCED. THIS INDICATES THE SYSTEM HAD ALARMED SEVERAL TIMES LEADING UP TO THE EVENT IN QUESTION AND THE ALARM MANAGEMENT SYSTEM WAS FUNCTIONING. FURTHER REVIEW OF THE DATA PROVIDED, FOUND THAT THERE COULD HAVE BEEN SOME SORT OF YELLOW ALARM OR AN TECHNICAL ALARM (INOP) REGARDING THE SP02 SENSOR ALARM AROUND THE REPORTED TIMEFRAME, AS THE SPO2 DATA IS MISSING\QUESTIONABLE IN THE TRENDS. BASED ON THE INFORMATION FOUND, THE SDE BELIEVED THAT THERE WAS AN ISSUE WITH THE SPO2 SENSOR\MEASUREMENT RIGHT AROUND 20:15-20:30 DURING THE HANDOVER. THIS IS REFLECTED BY THE SILENCES BELIEVED TO BE FOR THE INOP\YELLOW ALARMS. AROUND THE SAME TIME, IT LOOKS LIKE THE PATIENT WAS BEGINNING TO ENTER AN EPISODE OF SOME SORT, WHICH THE NURSE NOTICED JUST BEFORE,IN THE OR AT THE TIME, THE CONDITIONS WERE DETERIORATING ENOUGH TO ENTER A DESAT CONDITION AND ALARM. FROM THE OTHER ALARMS IN THE ALARM LOG, IT LOOKS LIKE THE HR RED LIMITS ARE TYPICALLY <40 OR >140, HOWEVER, IT WAS NOT CLEAR WHAT THE YELLOW ALARM LIMITS WERE AT THE TIME OF THE EVENT. THE CUSTOMER STATES THE VITALS WERE OUTSIDE THE ALARM LIMITS, HOWEVER, THE LIMITS WERE NOT PROVIDED. THE ONLY POTENTIAL FOUND BY THE SDE WAS A SPO2 ISSUE AROUND 20:29/20:30, HOWEVER THE VALUE WAS QUESTIONABLE. BASED ON THE REVIEW OF THE FILES BY THE SDE, THERE WAS NO PROOF THE PIIC WAS EXHIBITING BEHAVIOR OUTSIDE EXPECTED OPERATIONS, AND THE SILENCE ACTIONS CLEARLY SHOWED THE SECTOR ALARMED AND THERE WAS A RESPONSE TO THE ALARM. SINCE IT LOOKS LIKE THE SILENCE ACTION WAS TAKEN AT THE CENTRAL STATION (PIIC), IT IS POSSIBLE THE NURSE IN THE ROOM NOTICED THE VITALS BEING OUTSIDE THE LIMITS, AFTER THE ALARM HAD BEEN SILENCED BY ANOTHER USER.THIS INFORMATION WAS PROVIDED TO THE CUSTOMER VIA A RESPONSE LETTER. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. PATIENT INFORMATION REQUESTED, NONE AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2018 AT 20:30, THEY WERE CALLED TO A PATIENT, BECAUSE HE SHOWED LIFE-THREATENING VITAL SIGNS. THEY CHECKED IF THEY WERE ARTIFACTS. THIS WAS NOT SO AND THEY STARTED WITH THE MEASURES TO STABILIZE THE PATIENT. THE TREND SHOWED THAT THESE VALUES HAD ALREADY EXISTED FOR A FEW MINUTES. THEY WERE AT THE STATION DURING THAT WINDOW AND THEY REMEMBER NO ALARMS WERE HEARD. STANDING IN FRONT OF THE MONITOR, THERE WERE NO VISUAL INDICATIONS OF THE POOR VITAL SIGNS. THE MONITOR'S ALARMS WERE NOT TURNED OFF AT THIS TIME. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE REPORTED INCIDENT. ACCORDING TO THE CUSTOMER, THE PATIENT DIED. THE AGE, GENDER, HEIGHT, AND WEIGHT OF THE PATIENT WERE NOT AVAILABLE AT THE TIME THE REPORTING DECISION WAS DUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26258 INTELLIVUE MX700 PATIENT MONITOR PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS 865241

    Patients

    Seq Age Sex Outcome Treatment
    1 Death