BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 21307067 · Received February 4, 2025

    Report

    Report Number
    1218950-2025-000049
    Event Type
    Death
    Date Received
    February 4, 2025
    Date of Event
    January 4, 2025
    Report Date
    March 26, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838048645
    PMA / PMN Number
    K153702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE APPLICATION SPECIALIST (RAS) INTERVIEWED THE CUSTOMER, AND THEY REPORTED ON (B)(6) 2024 (TIME 2200 TO (B)(6) 2024 1:30AM) THEIR PATIENT (ICU BED239) PASSED AWAY. THE CUSTOMER STATED THAT THE PATIENT'S BEDSIDE MONITOR DID ALARM AS EXPECTED; HOWEVER, THE CLINICAL MANAGER (CM) HAD INQUIRIES REGARDING THE ALARM LOG AND THE APPLICATION CONFIGURATION SETTINGS. THE CM HAD THE FOLLOWING QUESTIONS: 1) THE CLINICAL AUDIT LOG DOES NOT SHOW THE "SPO2 SENSOR OFF" INOP ALARM EVENT WHY? 2) IS IT POSSIBLE TO CHANGE THE "SPO2 SENSOR OFF" ALARM SEVERITY CONFIG SETTING? 3) HOW IT THE ECG/HR EXTREME ALARM BEHAVIORS CONFIGURED? THE PHILIPS RAS REVIEWED FOLLOWING QUESTIONS AND NOTED A CENTRAL STATION WITH SOFTWARE B.02.X CANNOT LOG A "SENSOR OFF INOP" ALARM AS AN EVENT IN THE CLINICAL AUDIT LOG. THE CLINICAL AUDIT CAN LOG THE FOLLOWING INOPS EVENTS: ALL SERVER YELLOW OR RED INOP MESSAGES. ALL BATTERY INOP MESSAGES. ECG LEADS OFF. TRANSMITTER OFF. NO SPO2T. BATT LOW. THE CENTRAL STATION SERVER WITH SOFTWARE C AND GREATER WILL TRACK ALL THE TECHNICAL INOP ALARMS EVENT ON THE AUDIT LOG. THE RAS EXPLAINED THE SPO2 INOP TECHNICAL ALARMS ARE NOT CONFIGURABLE. THESE ALARMS CANNOT BE CONFIGURED TO YELLOW OR RED ALARM SEVERITY. THE CENTRAL STATION LOCAL SERVER INOPERATIVE SOUND VOLUME CAN BE SET TO BE LOUDER THAN THE CURRENT VOLUME. THE RAS EMAILED REFERENCES TO THE CUSTOMER, AND THEY CONFIRMED THE MONITOR GENERATED THE PATIENT'S HEART RATE LOW ALARMS AND THE ALARMS WERE SILENCED. CENTRAL STATION LOGS WERE REQUESTED BUT COULD NOT BE PROVIDED. THE CUSTOMER NOTED THE SYSTEM WORKED AS DESIGNED SINCE SPO2 SENOR BEING OFF WAS A BLUE ALARM AND DOES NOT RE-ALARM LIKE YELLOW AND RED ALARMS. THE QUESTIONS FROM THE CLINICAL MANGER WERE ANSWERED TO THEIR SATISFACTION AS THEY NOW UNDERSTAND THAT SPO2 SENSOR ALARM IS A BLUE ALARM. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT PASSED AWAY WHILE CONNECTED TO THE MONITOR AND THE CUSTOMER REQUESTED ASSISTANCE WITH THE ALARM LOGS AND CONFIGURATION SETTINGS. THE HOSPITAL DID NOT SHARE THE CAUSE OF DEATH AS THEY FELT IT WAS PROTECTED HEALTH INFORMATION (PHI). BIOMED INDICATED THE BEDSIDE MONITOR ALARMED AS EXPECTED BUT THE CLINICAL MANAGER WANTED TO REVIEW THE AUDIT LOG, SPECIFICALLY RELATED TO SPO2 SENSOR OFF INOP TECHNICAL ALARMS, SPO2 SENSOR OFF CONFIGURATION, AND ECG AND HEART RATE EXTREME ALARMS. GOOD FAITH EFFORTS (GFE) CONFIRMED THE DEVICE DID NOT CONTRIBUTE TO THE DEATH SINCE THE ISSUE IN QUESTION WAS SPO2 SENSOR OFF. THE SYSTEM GENERATED EKG ALARMS AND OTHER ALARMED APPROPRIATELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT PASSED AWAY WHILE CONNECTED TO THE MONITOR AND THE CUSTOMER REQUESTED ASSISTANCE WITH THE ALARM LOGS AND CONFIGURATION SETTINGS. BIOMED INDICATED THE BEDSIDE MONITOR ALARMED AS EXPECTED BUT THE CLINICAL MANAGER WANTED TO REVIEW THE AUDIT LOG, SPECIFICALLY RELATED TO SPO2 SENSOR OFF INOP TECHNICAL ALARMS, SPO2 SENSOR OFF CONFIGURATION, AND ECG AND HEART RATE EXTREME ALARMS. THERE WAS NO INDICATION THE MONITOR CONTRIBUTED TO THE DEATH; HOWEVER, GOOD FAITH EFFORTS ARE BEING PERFORMED FOR CONFIRMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47302 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389 00884838048645

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death