BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE X3

    MDR report key: 20344121 · Received October 1, 2024

    Report

    Report Number
    9610816-2024-00667
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    September 25, 2024
    Report Date
    October 4, 2024
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838082588
    PMA / PMN Number
    K171801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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.

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) INDICATED THAT THE ISSUE WAS ESCALATED WITH THE SENSOR MANUFACTURER MASSIMO. ACCORDING TO A PHILIPS PRODUCT SUPPORT ENGINEER (PSE), THE ISSUE WAS FOUND TO BE WITH THE MASIMO RAINBOW SPO2 MEASUREMENT TOGETHER WITH A MASIMO SENSOR AND A MASIMO ADAPTER CABLE. FOR ALL THREE ITEMS THE TECHNOLOGY IS OWNED BY MASIMO CORPORATION; PHILIPS DOES NOT HAVE ANY DETAILED KNOWLEDGE OF THIS TECHNOLOGY. ACCORDING TO THE INFORMATION ABOUT THIS CUSTOMER SITE, THE HOSPITAL WAS USING PHILIPS FAST SPO2 MEASUREMENT BEFORE THEY SWITCHED TO MASIMO RAINBOW SPO2 MEASUREMENT. THERE ARE DIFFERENCES BETWEEN THE PHILIPS FAST SPO2 ALGORITHM AND THE MASIMO RAINBOW SET ALGORITHM. THEREFORE, IN SOME SITUATIONS, THE MASIMO RAINBOW SET MEASUREMENT MIGHT BEHAVE DIFFERENTLY COMPARED TO THE PHILIPS FAST SPO2 MEASUREMENT. LIKEWISE, THE SENSOR APPLICATION OF THE MASIMO SPO2 SENSORS IS DIFFERENT TO THE APPLICATION OF THE PHILIPS SPO2 SENSORS. THE RSE INDICATED THAT LOCAL MEETINGS HAVE BEEN HELD WITH MASIMO REPRESENTATIVES AND THE CUSTOMER AND COME UP WITH A PLAN THAT INVOLVES FURTHER EDUCATION OF THE STAFF ON HOW TO USE THE MASIMO TECHNOLOGY IN THE BEST WAY. BASED ON THE INFORMATION AVAILABLE, THE CAUSE OF THE REPORTED PROBLEM IS THE MASIMO SPO2 SENSOR. THE REPORTED PROBLEM WAS NOT CONFIRMED. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE X3 DEVICE INDICATING THAT SPO2 MEASUREMENT FOR A PATIENT DROPPED TO 88%, BUT AN ARTERIAL GAS MEASUREMENT TAKEN ON THE SAME PATIENT AND TIME SHOWED 98%. THE STAFF TOOK SEVERAL ARTERIAL GAS MEASUREMENTS, SINCE THE PATIENT REALLY NEEDS A HIGH OXYGEN GAS LEVEL ON THE VENTILATOR. ALL GAS MEASUREMENTS SHOW THE SAME VALUE. THE SPO2 WAVE LOOKED GOOD WITH PERFUSION > 10. THE STAFF HAD TRIED CHANGING THE SPO2 BASE CABLE AND SENSOR, BUT THERE WAS NO DIFFERENCE. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45884 INTELLIVUE X3 INTELLIVUE X3 MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 867030 00884838082588

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown