BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MX550 PATIENT MONITOR

    MDR report key: 18638260 · Received February 5, 2024

    Report

    Report Number
    9610816-2024-00055
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Date of Event
    January 7, 2024
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838038783
    PMA / PMN Number
    K131872
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. REPORTING INSTITUTION PHONE NUMBER: (B)(6). REPORTER PHONE NUMBER: (B)(6).

    Additional Manufacturer Narrative · 0

    LOGS PROVIDED WERE REVIEWED AND ANALYZED BY PHILIPS PRODUCT SUPPORT ENGINEERING (PSE) AND IT WAS DETERMINED THAT THE PHILIPS EQUIPMENT WAS FUNCTIONING AS EXPECTED. PSE STATED THAT THE AUDIBLE ALARMING BEHAVIOR OF THE SPO2 SEARCHING INOP DID NOT CHANGE BETWEEN SW REV. L AND SW REV. N. THERE WAS NO TONE WITH REV L ON MX800 AND THERE IS NO TONE WITH REV N ON MX750.WITH THE MX750 SW REV. N, THE CUSTOMER IS USING X3 WITH MASIMO RAINBOW SET MEASUREMENT AND MASIMO SENSORS. THE MASIMO RAINBOW SET ALGORITHM IS OWNED BY MASIMO CORPORATION, AND SO IS THE MASIMO SENSOR TECHNOLOGY. PHILIPS CAN ONLY ASSIST IN DETAIL ON PHILIPS OWNED TECHNOLOGY. BASED ON THE INFORMATION PROVIDED IN THE CASE AND THE RESULT OF THE LOG EVALUATION PROVIDED BY THE PSE, THE CUSTOMER'S ALLEGATION COULD NOT BE CONFIRMED. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. BASED ON THE INFORMATION PROVIDED IN THE CASE AND THE RESULT OF THE LOG EVALUATION PROVIDED BY THE PSE, THE CUSTOMER'S ALLEGATION COULD NOT BE CONFIRMED. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THERE IS NO AUDIBLE ALARM ON THE INTELLIVUE MX550 PATIENT MONITOR FOR THE LOSS OF SPO2 MEASUREMENT. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1571730 INTELLIVUE MX550 PATIENT MONITOR INTELLIVUE MX550 PATIENT MONITOR MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 866066 00884838038783

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown