BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MX750 PATIENT MONITOR

    MDR report key: 19576836 · Received June 20, 2024

    Report

    Report Number
    9610816-2024-00307
    Event Type
    Malfunction
    Date Received
    June 20, 2024
    Date of Event
    May 20, 2024
    Report Date
    September 3, 2024
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838083332
    PMA / PMN Number
    K210906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS PROVIDED THAT AT THE TIME OF THE EVENT, THE MASIMO SPO2 PROBE DISPLAYED LOW MEASUREMENT VALUE OF 84% AND A STANDALONE SPO2 MEASUREMENT DISPLAYED 96%, WITH THE BLOOD GAS CONFIRMING THE STANDALONE MEASUREMENT WAS CORRECT AS THE BLOOD GAS WAS 95%. THE ISSUE WAS ESCALATED FOR TECHNICAL INVESTIGATION, AND SEVERAL TECHNICAL INOP ALARMS WERE PRESENT AT THE TIME POINTING TO USER/SENSOR/CABLE ISSUES. MASIMO CORPORATION NEEDS TO PERFORM A DETAILED INVESTIGATION FOR A ROOT CAUSE TO BE DETERMINED. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, WE WERE UNABLE TO REPLICATE THE REPORTED PROBLEM. THE REPORTED PROBLEM WAS NOT CONFIRMED. THE MX750 PATIENT MONITOR WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. CORRECTED THE CATALOG ITEM IDENTIFIER AND SERIAL NUMBER, AS THIS REPORT IS AGAINST THE MX750 MONITOR RATHER THAN THE X3. MFR REPORT # 9610816-2024-00345 FOR REPORT AGAINST THE X3.

    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. (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THIS PATIENT BEING PREPPED FOR AN ELECTIVE LEFT HIP REPLACEMENT WAS PLACED ON THEIR RIGHT SIDE AND SEDATION WAS ADMINISTERED. THE PATIENT BEGAN TO DESATURATE AND THE CLINICIAN CHECKED AIRWAY/TRACHEAL TUBE, LISTENED TO LUNGS, AND CHECKED PERIPHERAL PULSE AND CIRCULATION. THE SPO2 MEASUREMENT DISPLAYED ADEQUATE SIGNAL STRENGTH AND PERFUSION VALUES. THE SPO2 PROBE WAS MOVED TO OTHER FINGERS AND ALSO REPLACED WITH ANOTHER FORM OF SENSOR. OXYGEN WAS INCREASED TO 100% AND THEY PERFORMED PULMONARY RECRUITMENT; HOWEVER, THE SPO2 VALUES STEADILY DECREASED. WHEN SPO2 MEASURED AT 78%, ARTERIAL BLOOD GASES WERE DRAWN, REVEALING A SATURATION OF 95%. A STANDALONE PULSE OXIMETER WAS THEN USED TO MEASURE SPO2, REVEALING A SATURATION OF 97%. PER THE CUSTOMER, UNNECESSARY OXYGEN WAS DELIVERED AND THE OPERATION WAS DELAYED; HOWEVER, IT DOES NOT APPEAR ACTUAL HARM OCCURRED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2177712 INTELLIVUE MX750 PATIENT MONITOR INTELLIVUE MX750 PATIENT MONITOR MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 866471 00884838083332

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male