BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 23216391 · Received October 3, 2025

    Report

    Report Number
    1218950-2025-000575
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    September 11, 2025
    Report Date
    October 4, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K183387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: REPORTER INSTITUTION PHONE NUMBER:(B)(6). E1: REPORTER PHONE NUMBER: (B)(6). A PHILIPS REMOTE SERVICE ENGINEER (RSE) INTERVIEWED THE CUSTOMER WHO INDICATED ISSUES WITH THE ACCESS POINTS (APS) IN THE EMERGENCY DEPARTMENT (ED), NOTING THEY WERE NOT CONNECTED TO THE NETWORK. MULTIPLE TELE DEVICES WERE UNABLE TO ASSOCIATE WITH THE CENTRAL STATION, AND THE SURVEILLANCE SYSTEM IN PACU WAS OPERATING IN LOCAL MODE. THE CUSTOMER CONFIRMED THAT THERE WAS NO POWER OUTAGE WHEN THE ISSUE AROSE. WIRED MONITORING WAS STILL CONNECTING WITH THE CENTRAL STATION. THE RSE REMOTELY ACCESSED THE PRIMARY SERVER AND VERIFIED THE HOSTNAME OF THE CENTRAL STATION WITH THE CUSTOMER FOR ACCURACY. THE RSE DISCOVERED THE ROUTER AND SWITCH STATUSES WERE ALSO OFFLINE AND ATTEMPTED A POWER CYCLE ON THE ROUTER AND SWITCH; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. THE RSE CONFIRMED ALL ROUTERS AND SWITCHES WERE PINGABLE FROM FHM-MDPAC53986. THE NETWORK ENGINEER (NE) IDENTIFIED AN ISSUE WITH APC-1 AND TRIED TRANSFERRING SOME ED APS TO APC-2, WHICH DID NOT RESOLVE THE ISSUE. THE CUSTOMER REPORTED OTHER PORTS CONNECTED TO THE POE INJECTOR SHOWED NO LIGHTS, SUGGESTING THAT THE POE INJECTOR MIGHT BE CAUSING THE PROBLEM. PHILPS OFFERED ONSITE SUPPORT; HOWEVER, THE CUSTOMER DECLINED. THEY PLANNED TO REPLACE ONE POE INJECTOR IN AN ATTEMPT TO RESOLVE THE ISSUE. A GOOD FAITH EFFORT (GFE) RESPONSE CONFIRMED THE ROOT CAUSE HAD BEEN THE POWER INJECTOR/UPS IN THE NETWORK WERE FAULTY. THE CUSTOMER REPLACED THE TWO POWER INJECTORS RESULTING IN THE APS COMING BACK ONLINE TO RESOLVE THE ISSUE. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS CONFIRMED TO BE THE TWO POE INJECTORS. THE REPORTED PROBLEM WAS CONFIRMED. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WERE CONNECTIVITY ISSUES WITH THE SERVER. DEVICES IN LOCAL MODE. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487091 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX C.03.08

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown