BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE INFORMATION CENTER IX

    MDR report key: 10091637 · Received May 27, 2020

    Report

    Report Number
    1218950-2020-03092
    Event Type
    Malfunction
    Date Received
    May 27, 2020
    Date of Event
    May 18, 2020
    Report Date
    May 19, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H3 AND H6: A PHILIPS RESPONSE CENTER ENGINEER (RCE) SPOKE TO THE CUSTOMER, AND CONFIRMED THE REPORTED ISSUE OF BLUE WINDOW SCREENS WITH ONLY THREE ICONS ON DESKTOP. THE RCE CONFIRMED THAT THERE WAS NO PATIENT INCIDENT IN THIS CASE; THE CUSTOMER WAS JUST CONCERNED WITH THE POTENTIAL PATIENT IMPACT. THE CUSTOMER INFORMED THE RCE OVER THE PHONE THAT THEIR CLINICAL ENGINEERING WILL BE AT THE SITE AND TAKE CARE OF THE ISSUE. THE RCE REACHED OUT AGAIN AND THE NURSE THAT THE RCE SPOKE TO THAT KNEW THE ISSUE WAS NOT THERE. THE RCE BELIEVES THE ISSUE HAS BEEN RESOLVED, AS THE RCE DID NOT RECEIVE A CALL ABOUT THE ISSUE AGAIN. NO FURTHER INFORMATION IS AVAILABLE. THE PRODUCT MALFUNCTION WAS CONFIRMED; THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE CUSTOMER INDICATED THEY WOULD RESOLVE THE ISSUE THEMSELVES, AND NO FURTHER INFORMATION WAS RECEIVED. THE DEVICE REMAINS AT THE CUSTOMER SITE. 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 · 0

    THE CUSTOMER STATES SHOWING BLUE WINDOW SCREENS WITH ONLY THREE ICONS ON DESKTOP.THE DEVICE WAS IN USE ON A PATIENT. ADDITIONAL INFORMATION RECEIVED INDICATED THERE WAS NO PATIENT HARM.

    Additional Manufacturer Narrative · 1

    UNABLE TO CONFIRM SERIAL NUMBER. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. THE RECEIVED REPORT INDICATES A PATIENT WAS HARMED. INSUFFICIENT INFORMATION REGARDING THE EXTENT OR NATURE OF THE HARM WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES SHOWING BLUE WINDOW SCREENS WITH ONLY THREE ICONS ON DESKTOP. THE DEVICE WAS IN USE ON A PATIENT. PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554260 INTELLIVUE INFORMATION CENTER IX CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866389

    Patients

    Seq Age Sex Outcome Treatment
    1 Other