BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 20353695 · Received October 2, 2024

    Report

    Report Number
    1218950-2024-00696
    Event Type
    Death
    Date Received
    October 2, 2024
    Date of Event
    August 25, 2024
    Report Date
    December 12, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K183387
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    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. THE INTELLIVUE MP5, CATALOG # 865024, SERIAL # (B)(6), IN USE DURING THE EVENT IS REPORTED IN MFR REPORT NUMBER 9610816-2024-00665.

    Additional Manufacturer Narrative · 0

    INITIAL REVIEW OF THE LOGS DETERMINED THAT THERE WERE TECHNICAL INOPS FROM 11:05 UNTIL 11:55 BUT THE LOGS ARE STILL UNDER FURTHER REVIEW. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FUNCTIONAL TESTS WERE PERFORMED: THE PRODUCT SUPPORT ENGINEER AND CLINICAL PRODUCT SPECIALIST REVIEWED THE CLINICAL AUDIT LOG. THE CLINICAL AUDIT LOG PROVIDES A CHRONOLOGICAL RECORD OF THE ALARMS AND ACTIONS. PLEASE NOTE, THE DATA COLUMN IN THE LOG RECORD INDICATES THE DATE AND TIME DISPLAYED ON THE INFORMATION CENTER WHEN THE ENTRY OCCURRED. THE ACTION COLUMN CONTAINS THE TEXT GENERATED WHEN THE ALARM FIRST APPEARS, AND ENDED WHEN THE ALARM NO LONGER APPEARS IN THE SECTOR. PLEASE NOTE, THE TIME IN THE ACTION COLUMN SHOWS THE CLOCK TIME OF THE MONITORING DEVICE. THE CLOCK TIME MAY DRIFT UP TO 30 SECONDS BEFORE THE INFORMATION CENTER CLOCK SYNCHRONIZES TO THE MONITORING DEVICE CLOCK. THE CLINICAL AUDIT LOG SHOWS THE SPO2 ALARMS WERE TURNED OFF BY USER ON (B)(6) 2024, AT 18:41:05 AT THE MONITOR. THE ALARMS REMAINED OFF UNTIL (B)(6) 2024, AT 12:37:32. THE ALARMS WERE TURNED ON BY USER AT THE BEDSIDE. WHEN THE SPO2 ALARMS ARE OFF, THE MONITOR WILL NOT ALARM FOR SPO2 LOW, SPO2 HIGH, OR SPO2 DESAT. WHEN AN INDIVIDUAL MEASUREMENT ALARM IS SWITCHED OFF, THE ALARMS OFF SYMBOL IS SHOWN BESIDE THE MEASUREMENT NUMERIC AT BOTH THE BEDSIDE MONITOR AND THE PIC IX. WHEN ALARMS ARE OFF, INOP MESSAGES ARE DISPLAYED, BUT THE INOP TONES ARE NOT SOUNDED. (B)(6) 2024 18:41:05, (B)(6) HOSPITAL, A6021A, SPO2 - ALARMS FROM ON TO OFF, MON6021, ALARM ON/OFF. (B)(6) 202412:37:25, (B)(6) HOSPITAL, A6021A, SPO2 - ALARMS OFF, MON6021, ALARM ON/OFF. (B)(6) 2024 12:37:32, (B)(6) HOSPITAL, A6021A, SPO2 - ALARMS FROM OFF TO ON, MON6021, ALARM ON/OFF. (B)(6) 2024 12:40:04, (B)(6) HOSPITAL, A6021A, SPO2 - ALARMS ON, MON6021, ALARM ON/OFF. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED WE WERE UNABLE TO REPLICATE THE REPORTED PROBLEM. THE REPORTED PROBLEM WAS NOT CONFIRMED. BASED ON THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THE DEVICES WERE ALARMING AS INTENDED BASED ON THE USER SELECTED SETTINGS. THE MONITOR REMAINS IN USE AT THE CUSTOMER SITE, PASSED ALL SAFETY TESTS, AND THE TECHNICAL CONSULTANT (TC) VERIFIED LOW SPO2 ALARMS OCCURRED. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS CONFIRMED THE PATIENT HAD DESATURATED AND THE NURSES WERE NOT AWARE OF THE CHANGE IN CONDITION. THE PATIENT WAS EMERGENTLY INTUBATED AND TRANSFERRED TO CVICU WHERE SHE LATER PASSED AWAY. IT WAS INDICATED THE ALARM WAS NOT AUDIBLE AT THE BEDSIDE OR CENTRAL STATION. THE CUSTOMER WAS ALSO NOT SURE WHETHER THE ALARMS WERE SET AND FAILED OR NOT PROPERLY SET UP. WHEN STAFF REVIEWED THE WAVEFORMS, IT WAS NOTED THE SPO2 HAD BEEN TRENDING DOWNWARD FOR APPROXIMATELY 10 MINUTES PRIOR TO THE BRADYCARDIA ALARM. A PRELIMINARY REVIEW OF THE CLINICAL AUDIT LOGS CONFIRMED THE LOW HEART RATE AND BRADYCARDIA ALARM WAS GENERATED AT THE TIME OF THE EVENT BUT NO SPO2 ALARMS WERE NOTED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21764 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death