BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE MX450 PATIENT MONITOR

    MDR report key: 17332668 · Received July 17, 2023

    Report

    Report Number
    9610816-2023-00359
    Event Type
    Death
    Date Received
    July 17, 2023
    Date of Event
    July 2, 2023
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838038769
    PMA / PMN Number
    K130849
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTING INSTITUTION PHONE NUMBER: (B)(6). REPORTER PHONE NUMBER: (B)(6). 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

    PHILIPS HAS RECEIVED A COMPLAINT ON THE INTELLIVUE MX450 PATIENT MONITOR INDICATING THAT THE MONITOR IN ROOM 506 DID NOT GENERATE ANY ALARMS DURING THE NIGHT FROM (B)(6) 2023 TO (B)(6) 2023. THE DEVICE WAS IN USE MONITORING A PATIENT AT THE TIME OF THE REPORTED EVENT. THE PATIENT PASSED AWAY AT 02:00 ON (B)(6) 2023. A PHILIPS REMOTE SERVICE ENGINEER (RSE) ANALYZED THE PIC IX CLINICAL AUDIT TRAIL CHECKING FOR MODIFICATION OF ALARM LIMITS, TRIGGERING OF ALARMS (VISUAL AND AUDIBLE). THE RSE FINDINGS REGARDING THE INCIDENT ON (B)(6) 2023, IN ROOM 506P MONITORED BY MONITOR MON1 WERE THE FOLLOWING: -THE SPO2 (BLOOD OXYGEN SATURATION LEVELS) PARAMETER WAS DISABLED FROM 9:35 TO 12:17 (2:40 NO MONITORING). -THE (ELECTROCARDIOGRAM) ECG PARAMETER WAS DISABLED AT 11:19, THEN REACTIVATED 1 HOUR LATER AT 12:15 (1 HOUR OF ABSENCE OF MONITORING): -THE SPO2 PARAMETER WAS REACTIVATED THEN DISABLED SEVERAL TIMES: THE NEXT ALARMS START AGAIN AFTER 4:00. (B)(6)2023 04:01:56 MY INSTITUTION 506P PAT MON1 ACKNOWLEDGED (B)(6)2023 04:01:16 YELLOW ALARM TONE EMITTED. PIC IX: C_CLT_USINV ALERT SOUND (B)(6)2023 04:01:16 MY INSTITUTION 506P PNIS 211 >160 GENERATED AT 04:01:06. PIC IX: C_CLT_USINV YELLOW ALARM (B)(6)2023 04:01:14 YELLOW ALARM TONE EMITTED. PIC IX: PC_USINV ALERT SOUND (B)(6)2023 04:01:14 MY INSTITUTION 506P PNIS 211 >160 GENERATED AT 04:01:06. PIC IX: PC_USINV YELLOW ALARM AT THE TIME OF THE DEATH, AROUND 2:00 IN THE MORNING, THE SPO2 AND PULSE ALARMS WERE DISABLED. THE RSE STATED THAT THERE WERE A NUMBER OF TECHNICAL ALARMS REGARDING THE DISCONNECTION OF THE SPO2 SENSOR AND ECG LEADS. IN ADDITION, THE SPO2 AND ECG MEASUREMENTS WERE AT TIMES DEACTIVATED BY THE USER. THE RSE EXPLAINED TO CUSTOMER THAT "SPO2 SET TO DISABLED" MEANS THAT THE MEASUREMENT IS VOLUNTARILY DISABLED, AND NO GRAPH OR NUMERICAL VALUE APPEARS FOR THE PARAMETER ON THE MONITOR AS WELL AS ON THE CENTRAL STATION. THE SAME APPLIES TO "ECG DISABLED". A NON-INVASIVE BLOOD PRESSURE "(NIBP) 211>160" MEANS THAT THE ALARM LIMIT IS 160, AND THAT THE UPPER VALUE OF 211 HAS TRIGGERED AN ALARM. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THERE IS OBJECTIVE EVIDENCE TO CONCLUDE THE DEVICE ALARMED AS EXPECTED AND THERE WAS NO MALFUNCTION OF THE MONITOR. AT THE TIME OF THE DEATH, AROUND 2:00 IN THE MORNING, THE SPO2 AND PULSE ALARMS WERE DISABLED BY THE USER. PHILIPS INTELLIVUE MX450 PATIENT MONITOR HAS NOT CAUSED OR CONTRIBUTED TO THE EVENT; IT APPEARS ALARM MANAGEMENT AND AWARENESS BY THE USER WAS A CONTRIBUTING FACTOR AS THERE WAS ALARM ACKNOWLEDGMENT AT THE MONITOR AND CENTRAL STATION. THE DEVICE IS OPERATIONAL AND REMAINS AT THE CUSTOMER SITE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE MONITOR IN ROOM 506 DID NOT GENERATE ANY ALARMS DURING THE NIGHT FROM (B)(6) 2023 TO (B)(6) 2023. THE DEVICE WAS IN USE MONITORING A PATIENT AT THE TIME OF THE REPORTED EVENT. THE PATIENT PASSED AWAY AT 02:00 ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616481 INTELLIVUE MX450 PATIENT MONITOR INTELLIVUE MX450 PATIENT MONITOR MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 866062 00884838038769

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death