BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE X3

    MDR report key: 20438260 · Received October 14, 2024

    Report

    Report Number
    9610816-2024-00698
    Event Type
    Malfunction
    Date Received
    October 14, 2024
    Date of Event
    September 16, 2024
    Report Date
    October 14, 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 PRODUCT SUPPORT ENGINEER (PSE) REVIEWED THE INFORMATION/LOGS PROVIDED. THE PSE STATED THAT THE REPORTED ISSUE IS ABOUT 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. THEREFORE, WE CAN ONLY PROVIDE PARTIAL INVESTIGATION RESULTS. FOR A DETAILED ANALYSIS, THE INVOLVEMENT OF MASIMO CORPORATION IS REQUIRED. IN REVIEW OF THE LOGS PROVIDED THE PSE PROVIDED THE FOLLOWING INFORMATION: IN THE LOGS PROVIDED (SEE ATTACHED EXCERPT FROM THE CENTRAL STATION AUDIT LOG), IT CAN BE SEEN THAT THE SPO2 VALUE DECREASED FROM 88 (SPO2 ALARM 88 <90 AT 08:26:42) TO 58 (SPO2 ALARM 58 <64 AT 09:01:45). IT WAS STATED THAT THE CUSTOMER COMPARED THESE VALUES WITH THE SPO2 VALUES FROM ANOTHER DEVICE. HOWEVER, WE DO NOT HAVE ANY INFORMATION WHICH DEVICE FROM WHICH MANUFACTURER WITH WHICH SPO2 ALGORITHM AND SPO2 SENSORS WAS USED FOR THE COMPARISON. WHEN LOOKING FURTHER INTO THE AUDIT LOG, THERE ARE SEVERAL ENTRIES FOR SPO2 INOPS, WHICH MIGHT INDICATE THAT THERE IS NO STABLE SPO2 MEASUREMENT AT THE ALLEGED TIME. FOR EXAMPLE, THERE ARE OCCURRENCES OF ¿SPO2 SENSOR OFF¿ AND ¿SPO2 NO SENSOR¿ (SEE ATTACHED EXCERPT FROM THE CENTRAL STATION AUDIT LOG). AN ¿SPO2 SENSOR OFF¿ INOP IS ISSUED, IF THE SPO2 SENSOR IS NOT PROPERLY APPLIED TO THE PATIENT. HOWEVER, AN ¿SPO2 SENSOR OFF¿ INOP MIGHT ALSO RARELY OCCUR IN CASE OF SPECIFIC SENSOR OR ADAPTER CABLE DEFECTS. AN ¿SPO2 NO SENSOR¿ INOP IS ISSUED, IF THE SPO2 SENSOR IS NOT PROPERLY CONNECTED. HOWEVER, IT MIGHT ALSO BE CAUSED BY A DEFECTIVE ADAPTER CABLE OR SENSOR. SINCE THE CUSTOMER IS USING MASIMO SENSORS & ADAPTER CABLES & MASIMO RAINBOW SET MEASUREMENT, ONLY MASIMO HAS DETAILED KNOWLEDGE ABOUT THE ALGORITHM AND THE PRODUCTS USED. THEREFORE, IT WOULD FALL INTO THE RESPONSIBILITY OF MASIMO CORPORATION TO ADVISE ABOUT THIS. ACCORDING TO THE INFORMATION OBTAINED 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. WE WOULD ADVISE TO FURTHER COOPERATE WITH MASIMO CORPORATION REGARDING THE BEHAVIOR OF THE MASIMO RAINBOW SPO2 MEASUREMENT AS WELL AS THE MASIMO SPO2 SENSOR APPLICATION. MASIMO OWNS THE MASIMO RAINBOW SET MEASUREMENT ALGORITHM AS WELL AS THE MASIMO SENSOR AND ADAPTER CABLE TECHNOLOGY. THUS, ONLY MASIMO CORPORATION WILL BE ABLE TO IDENTIFY THE ROOT CAUSE FOR THE OBSERVED ISSUE AND PROPOSE A SOLUTION. THE REMOTE SUPPORT ENGINEER (RSE) ALSO STATED THAT MASIMO AND PHILIPS ARE ACTIVELY INVESTIGATING THE ISSUE. IT WAS ADVISED THAT THE CUSTOMER FURTHER COOPERATE WITH MASIMO CORPORATION REGARDING THE BEHAVIOR OF THE MASIMO RAINBOW SPO2 MEASUREMENT AS WELL AS THE MASIMO SPO2 SENSOR APPLICATION AS PHILIPS DOES NOT HAVE ANY DETAILED KNOWLEDGE OF THIS TECHNOLOGY. THE RSE HAS CONFIRMED THAT THE LOCAL MASIMO REPRESENTATIVES HAVE BEEN ONSITE AND LOOKED INTO THE ISSUE TOGETHER WITH THE CUSTOMER AND FOUND THAT THE USERS NEED FURTHER TRAINING WHEN IT COMES TO THE APPLICATION OF THE SENSORS AND OVERALL UNDERSTANDING OF THE MEASUREMENT BEHAVIOR. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. REPORTING INSTITUTION PHONE # (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SPO2 VALUE SUDDENLY DECREASED TO 69%. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744704 INTELLIVUE X3 INTELLIVUE X3 MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 867030 00884838082588

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown