BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFORMATION CENTER IX

    MDR report key: 9610208 · Received January 21, 2020

    Report

    Report Number
    1218950-2020-00422
    Event Type
    Death
    Date Received
    January 21, 2020
    Date of Event
    January 10, 2020
    Report Date
    January 13, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838048645
    PMA / PMN Number
    K102495
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A PHILIPS RESPONSE CENTER ENGINEER (RCE) SPOKE TO THE CUSTOMER. THE CUSTOMER HAD QUESTIONS ON HOW TO VIEW RETROSPECTIVE DATA. THERE WAS NO CONCERN OVER THE DEVICE FUNCTION. THERE WAS NO DELAY IN TREATMENT, AND THE CUSTOMER DOES NOT FEEL THE DEVICE WAS A CONTRIBUTING FACTOR IN THE PATIENT DEATH. THERE WAS NO PRODUCT MALFUNCTION; THE CUSTOMER HAD QUESTIONS ON HOW TO VIEW RETROSPECTIVE DATA. THE RCE PROVIDED INFORMATION ON HOW TO VIEW RETROSPECTIVE DATA FOR THIS INCIDENT. THE DEVICE REMAINS IN USE AT THE CUSTOMER SITE. NO SUBSEQUENT CALLS HAVE BEEN LOGGED FOR THIS DEVICE/ISSUE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A PATIENT DEATH AND THEY WANTED TO RETRIEVE DATA FROM (B)(6) 2020. THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74300 INTELLIVUE INFORMATION CENTER IX CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866389 00884838048645

    Patients

    Seq Age Sex Outcome Treatment
    1 Death