BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MX750 PATIENT MONITOR

    MDR report key: 13391644 · Received January 31, 2022

    Report

    Report Number
    9610816-2022-00048
    Event Type
    Malfunction
    Date Received
    January 31, 2022
    Date of Event
    January 17, 2022
    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
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE QTC MEASUREMENT IS INACCURATE WHEN COMPARED TO MANUAL ANALYSIS OF THIS VALUE. THE QT INTERVAL DESCRIBES THE PERIOD FROM THE START OF THE Q WAVE TO THE END OF THE T WAVE ON AN ELECTROCARDIOGRAM. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE QTC MEASUREMENT IS INACCURATE WHEN COMPARED TO MANUAL ANALYSIS OF THIS VALUE. THE QT INTERVAL DESCRIBES THE PERIOD FROM THE START OF THE Q WAVE TO THE END OF THE T WAVE ON AN ELECTROCARDIOGRAM. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541860 INTELLIVUE MX750 PATIENT MONITOR INTELLIVUE MX750 PATIENT MONITOR MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 866471 00884838083332

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown