BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFORMATION CENTER IX

    MDR report key: 8297544 · Received February 1, 2019

    Report

    Report Number
    1218950-2019-00928
    Event Type
    Death
    Date Received
    February 1, 2019
    Date of Event
    December 25, 2018
    Report Date
    January 9, 2019
    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
    CA, US
    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 BIOMEDICAL ENGINEER (BIOMED). THE BIOMED WAS ATTEMPTING TO OBTAIN TRAINING INFORMATION FOR THE NURSES. THEY HAD SOME STRIPS, HOWEVER, THEY WANTED HOURS OF GENERAL REVIEW DATA. THERE WAS NO PRODUCT MALFUNCTION, OR ANY DELAY IN SILENCING OR HEARING THE ALARMS. THE BIOMED STATED THE DEVICE WAS NOT A FACTOR IN THE PATIENT DEATH. THE RCE ASSISTED THE BIOMED IN OBTAINING THE LOG DATA REQUESTED BUT THE LOG DATA WAS NOT PROVIDED TO THE RCE. THE DEVICE REMAINS AT THE CUSTOMER SITE. NO SUBSEQUENT CALLS LOGGED FOR THIS DEVICE/ISSUE. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHILIPS WITH A REQUEST FOR RETRIEVAL OF DATA AFTER THE DEATH OF A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89696 INTELLIVUE INFORMATION CENTER IX CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866389 00884838048645

    Patients

    Seq Age Sex Outcome Treatment
    1 Death