BEUDAMED
    FDA Adverse Event Death Summary report: N

    MP70 INTELLIVUE PATIENT MONITOR

    MDR report key: 7435867 · Received April 17, 2018

    Report

    Report Number
    9610816-2018-00094
    Event Type
    Death
    Date Received
    April 17, 2018
    Date of Event
    March 18, 2018
    Report Date
    March 18, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K021300
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO MALFUNCTION OF THE DEVICE. A PHILIPS RESPONSE CENTER ENGINEER (RCE) SPOKE TO THE CUSTOMER, AND FOUND NO ISSUES WITH THE DEVICE; THE MONITOR ALARMED AS EXPECTED. THE MONITOR DISPLAYED THE PATIENT PERFUSION INDEX (PERF) = .18, WHICH IS NOT ACCEPTABLE; THEREFORE, THE MONITOR PRODUCED AN INOP MESSAGE ¿LOW PERFUSION¿ . THE CLINICAL USER HAD REPLACED THE SENSOR AND CABLE, BUT PROBLEM CONTINUED. THE RCE EXPLAINED THAT QUESTIONABLE/ INTERPRETABLE VALUES WILL NOT FLOW OVER TO EPIC; IN THIS CASE THE PATIENT PLETH WAVE VERY SMALL (PATIENT VERY SICK PERF VALUE = .18). THE RCE RECOMMENDED THAT THE USER CHANGE THE SPO2 SENSOR SITE/LOCATION, AND THEN TEST WITH A PORTABLE MONITOR TO CONFIRM. WE WILL CONSIDER THAT THE CUSTOMER RESOLVED THE ISSUE USING THE INFORMATION PROVIDED BY THE RCE, AND THAT THE DEVICE REMAINS IN USE AT THE CUSTOMER SITE, AS NO SUBSEQUENT CALLS HAVE BEEN LOGGED FOR THIS DEVICE/ISSUE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME. PATIENT INFORMATION HAS BEEN REQUESTED AND NOT AVAILABLE AT THE TIME OF REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SPO2 IS NOT GOING THROUGH TO THE EPIQ, BUT ALL OF THE OTHER VITALS ARE, AND ALSO THE PATIENT IS CODING. THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280816 MP70 INTELLIVUE PATIENT MONITOR PATIENT MONITOR DSI PHILIPS MEDICAL SYSTEMS M8007A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death