BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFORMATION CENTER IX

    MDR report key: 7906382 · Received September 25, 2018

    Report

    Report Number
    1218950-2018-07529
    Event Type
    Death
    Date Received
    September 25, 2018
    Date of Event
    September 9, 2018
    Report Date
    September 13, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED THE CUSTOMER CARE SOLUTIONS CENTER FOR SUPPORT AND A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR ONSITE EVALUATION. THE FSE PROVIDED STRIPS AND LOG FILES WHICH WERE REVIEWED BY A PHILIPS PRODUCT SUPPORT ENGINEER AND A PHILIPS R & D ENGINEER. THE STRIPS SHOW PERIODS OF TIME WHERE THE TELEMETRY SIGNAL IS NO LONGER PRESENT AND A "NO DATA TELE" INOP MESSAGE IS CLEARLY PROVIDED WHICH IS GENERATED AT THE INFORMATION CENTER. THIS IS EXPECTED BEHAVIOR WHEN THE SIGNAL IS NO LONGER PRESENT. IT WAS FOUND THAT THE MX40 DEVICE ITSELF REBOOTED 4 TIMES BETWEEN 16:19 AND 16:26. AT 16:34 THE MX40 WENT INTO STANDBY AND WAS TAKEN OUT OF STANDBY AT 16:47. THE R & D ENGINEER CONFIRMED MANY MX40 REBOOT ISSUES ARE ASSOCIATED WITH DIRTY BATTERY TRAYS AFFECTING BATTERY CONTACTS OR OLDER RECHARGEABLE BATTERY USE RECOMMENDING THAT THE CUSTOMER INSPECT THEM FOR THESE ISSUES. ADDITIONALLY, THE MX40 SOFTWARE VERSION IN USE AT B.04.60, AND AN UPDATE TO B.06.51, IS AVAILABLE THAT CONTAINS RESOLUTION FOR SOME APPLICATION RESTART ISSUES. WE WILL CONSIDER THAT THE CUSTOMER RESOLVED THE ISSUE USING THE INFORMATION PROVIDED, 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. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT MONITORED VIA AN MX40 TELEMETRY DEVICE AT THE INFORMATION CENTER IX CODED AND EXPIRED ON (B)(6). THE MX40 WAS NOTED TO HAVE BEEN INTERMITTENTLY GOING OFFLINE/DISCONNECTING FROM THE INFORMATION CENTER AND THE DEVICE WAS OFFLINE WHEN THE PATIENT CODED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747029 INTELLIVUE INFORMATION CENTER IX CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866389

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death