BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFORMATION CENTER IX

    MDR report key: 8949658 · Received August 30, 2019

    Report

    Report Number
    1218950-2019-06549
    Event Type
    Death
    Date Received
    August 30, 2019
    Date of Event
    August 2, 2019
    Report Date
    August 22, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 INDICATED THAT THE DEVICE WAS NOT A CONTRIBUTING FACTOR IN THE PATIENT DEATH, AND DOES NOT QUESTION THE PHILIPS EQUIPMENT. THE REPORT WAS CREATED ONLY DUE TO THE PATIENT'S DEATH. THE BIOMED NEEDED ASSISTANCE IN RETRIEVING PATIENT DATA FROM THE PIC IX, AS THEY WANTED TO RETRIEVE THE NAME OF A FICTITIOUS PATIENT IN THE UNIT BECAUSE HE WANTED TO RETRIEVE ECG DATA. THERE WAS NO ALLEGED MALFUNCTION OF THE DEVICE AND THE BIOMED ONLY NEEDED ASSISTANCE IN RETRIEVING PATIENT DATA FROM THE PIC IX. THE RCE ASSISTED THE BIOMED, BUT THE FICTITIOUS NAME COULD NOT BE FOUND. NO PARTS WERE ORDERED AND NO REPAIR WAS WARRANTED. WE WILL CONSIDER THAT THE CUSTOMER WAS PROVIDED INFORMATION ON RETRIEVING THE REQUESTED DATA, 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THERE WAS A DEATH OF A NEWBORN. THE CUSTOMER WANTED TO PULL ECG DATA. THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744699 INTELLIVUE INFORMATION CENTER IX CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866389

    Patients

    Seq Age Sex Outcome Treatment
    1 Death