BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFORMATION CENTER IX

    MDR report key: 8596355 · Received May 9, 2019

    Report

    Report Number
    1218950-2019-03359
    Event Type
    Death
    Date Received
    May 9, 2019
    Date of Event
    April 29, 2019
    Report Date
    May 1, 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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PRODUCT MALFUNCTION; THE CUSTOMER WAS NEEDED ASSISTANCE IN GATHER INFORMATION FORM THE PIC IX SYSTEM. THE RCE ASSISTED THE BIOMED WITH SEARCHING IN CLINICAL AUDIT TRAIL LOG AND GAVE STEPS ON HOW TO EXPORT THE DATA TO A USB MEDIA KIT. THE BIOMED WOULD LIKE TO PRINT OFF A ONE HOUR BLOCK FROM GENERAL REVIEW. THE RCE EXPLAINED THAT THEY CAN ONLY DO A START AND STOP FOR ABOUT 12 MINUTES OF ECG AT A TIME, AND THAT THE WILL HAVE TO WORK THEIR WAY BACKWARD 12 MINUTES AT A TIME. 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. NO SUBSEQUENT CALLS HAVE BEEN LOGGED FOR THIS DEVICE/ISSUE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DIED WHILE HOOKED UP TO A PHILIPS PIIC IX SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390576 INTELLIVUE INFORMATION CENTER IX CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866389 00884838048645

    Patients

    Seq Age Sex Outcome Treatment
    1 Death