BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 23180345 · Received September 30, 2025

    Report

    Report Number
    1218950-2025-000561
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Date of Event
    September 4, 2025
    Report Date
    September 30, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K183387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE TO THE BIOMED WHO REPORTED THAT MULTIPLE SYSTEMS WERE REPORTED AS DOWN, WITH THE PHILIPS SUPPLIED NETWORK (PSCN) NOT CONNECTING. DURING TROUBLESHOOTING IT WAS IDENTIFIED THAT CORE A APPEARED OFFLINE AND WAS NOT REACHABLE. ATTEMPTS TO CONNECT TO CORE B WERE UNSUCCESSFUL, AS SESSIONS DISCONNECTED AFTER A FEW SECONDS. ALL SERVERS AT THIS SITE ARE VIRTUAL MACHINES. THE RSE ADVISED THE CUSTOMER TO CONFIRM WHETHER ANY CHANGES HAD BEEN MADE BY THEIR INFORMATION TECHNOLOGY (IT) TEAM. UPON INVESTIGATION, THE CUSTOMER IT TEAM IDENTIFIED AND RESOLVED A ROUTER ISSUE. ONCE THE ROUTER (SG-2C-CORE-A 172.28.32.2) CONNECTION WAS RESTORED, ALL SITE HOSTS REPORTED ONLINE AND NORMAL OPERATIONS. THE CUSTOMER IT TEAM RESOLVED THE ISSUE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT INFORMATION CENTER IX IS NOT CONNECTING AND HALF THE SYSTEM IS DOWN. 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
    1673624 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown