BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE X3

    MDR report key: 20369841 · Received October 4, 2024

    Report

    Report Number
    9610816-2024-00675
    Event Type
    Malfunction
    Date Received
    October 4, 2024
    Date of Event
    September 19, 2024
    Report Date
    October 7, 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

    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. FOR THIS PATIENT, THE STAFF CHANGED THE LOCATION OF THE SENSOR TO ANOTHER FINGER AND ALSO TRIED A DIFFERENT HAND. IN THE END, THE STAFF HAD TO DISCONNECT THE BASE CABLE FROM THE SENSOR AND RETAKE THE MEASUREMENT TO RESOLVE THE ISSUE FOR THIS PATIENT. 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. BOX E: REPORTING INSTITUTION PHONE #: (B)(6). REPORTER PHONE #: (B)(6).

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION WAS FOUND THAT INDICATED THAT THE DATE PHILIPS BECAME AWARE OF THIS ISSUE WAS 27SEP2024, INSTEAD OF 01OCT2024. BOX G3 UPDATED TO THE CORRECT DATE OF 27SEP2024.

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON AN INTELLIVUE X3 DEVICE INDICATING THERE WAS DEVIATION IN THE SATURATION MEASUREMENT WITH MASIMO EAR PROBE. THE PATIENT SHOWED AN SPO2 VALUE OF 87% ON THE PHILIPS MONITOR. A PORTABLE PULSE OXIMETER SHOWS 95% AND WHEN THEY PERFORMED AN ARTERIAL BLOOD GAS MEASUREMENT THE VALUE WAS 96%. SINCE THE PATIENT WAS ADMITTED ON THE 15TH OF SEPTEMBER THE SPO2 MEASUREMENT HAS BEEN PROBLEMATIC; WRONG SPO2 VALUES DESPITE FULL PERFUSION. SPO2 MONITORING IS INTERRUPTED VERY FREQUENTLY AND SHOWS ¿?¿, EVEN THOUGH THE PATIENT IS NOT MOVING. THE STAFF HAS TRIED WITH BOTH FINGER PROBE AND EAR PROBE. IT IS NOT POSSIBLE TO MONITOR THE PATIENT'S SATURATION ADEQUATELY WITH THE MONITORING SYSTEM, WHICH IS IMPORTANT SINCE THE PATIENT IS INTUBATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173204 INTELLIVUE X3 INTELLIVUE X3 MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 867030 00884838082588

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown