BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFO CENTER IX

    MDR report key: 11702719 · Received April 21, 2021

    Report

    Report Number
    1218950-2021-10404
    Event Type
    Death
    Date Received
    April 21, 2021
    Date of Event
    October 1, 2020
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E! UPDATED CORRECT INSTITUTION, ADDRESS AD COUNTRY.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER INFORMED A CLINICAL PRACTICE SPECIALIST (CPS) ABOUT THE ISSUE. THE CPS WAS INFORMED THAT THE CUSTOMER WAS AWARE THAT THEIR WAS NO MALFUNCTION OF THE DEVICE AND THAT THE ISSUE WAS USER RELATED. THE CUSTOMER SIMPLY WANTED TO BRING TO THE ATTENTION OF THE BUSINESS UNIT THAT THEY BELIEVE A WARNING MESSAGE SHOULD BE INSTATED WHEN MONITORING OF A PREVIOUS PATIENT RESUMES AFTER THEY RECEIVE A PACEMAKER. THERE WAS NO PRODUCT MALFUNCTION OF THE PHILIPS DEVICE. THE DEATH WAS CAUSED BY A USER ERROR WHERE THE CLINICAL USER FAILED TO UPDATE THE PATIENT MONITOR TO REFLECT THE FACT THAT THE PATIENT WAS IMPLANTED WITH A PACEMAKER. THE CPS BROUGHT THE ISSUE TO THE ATTENTION OF THE BUSINESS UNIT PER THE CUSTOMERS REQUEST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPIRED IN (B)(6) 2020. THE PATIENT WAS ADMITTED AND MONITORED WITHOUT ANY PACEMAKER. LATER THE PATIENT RECEIVED A PACEMAKER BUT THE CUSTOMER FAILED TO UPDATE THE METHOD OF WHICH THE PATIENT WAS BEING MONITORED TO REFLECT THE PACEMAKER. THE CUSTOMER BELIEVED THEY SHOULD HAVE BEEN NOTIFIED TO CHANGE THE MONITORING METHOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPIRED IN (B)(6) 2020. THE PATIENT WAS ADMITTED AND MONITORED WITHOUT ANY PACEMAKER. LATER THE PATIENT RECEIVED A PACEMAKER BUT THE CUSTOMER FAILED TO UPDATE THE METHOD OF WHICH THE PATIENT WAS BEING MONITORED TO REFLECT THE PACEMAKER. THE CUSTOMER BELIEVED THEY SHOULD HAVE BEEN NOTIFIED TO CHANGE THE MONITORING METHOD. THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597683 INTELLIVUE INFO CENTER IX INTELLIVUE INFO CENTER IX MHX PHILIPS NORTH AMERICA LLC 866023

    Patients

    Seq Age Sex Outcome Treatment
    1 Death