BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 24541702 · Received March 8, 2026

    Report

    Report Number
    1218950-2026-100118
    Event Type
    Malfunction
    Date Received
    March 8, 2026
    Date of Event
    February 10, 2026
    Report Date
    April 29, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K183387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED BY A PHILIPS REMOTE SERVICE ENGINEER (RSE) WHICH INCLUDED INTERVIEWING THE CUSTOMER AND ASSISTING THEM WITH TROUBLESHOOTING STEPS. THE CUSTOMER STATED THERE WAS NO POWER INTERRUPTION WHEN THE ISSUE OCCURRED. THE RSE INDICATED THERE WAS A MALFUNCTION ON CISCO SWITCHES AND THIS WAS A HOSPITAL-WIDE ISSUE. THE RSE RECOMMENDED REBOOTING THE UNIT TO RESOLVE THIS ISSUE. A TECHNICAL SUPPORT NETWORK ENGINEER (TSNE) WAS CONTACTED REGARDING THIS ISSUE AND USED PHILIPS REMOTE SERVICES (PRS) TO CHECK THE DEVICES STATUS AND FOUND SEVERAL SWITCHES OFFLINE AND SERVERS OFFLINE. THESE FINDINGS ALONG WITH OTHER INFORMATION WERE RELAYED TO A NATIONAL SUPPORT SPECIALIST (NSS) AND A ROOT CAUSE ANALYSIS (RCA) WAS CONDUCTED. AFTER REVIEWING LOGS, IT WAS DISCOVERED THERE WAS A DAMAGED SMALL FORM-FACTOR PLUGGABLE (SFP) OR FIBER PATCH/RUN ON CORE B PORT GI1/0/9 CAUSING THRESHOLD VIOLATIONS AND PORT FLAPPING LEAD TO EXTENSIVE SHIELDED TWISTED PAIR (STP) RECONVERGENCE AND ERR-DISABLED TRUNKS. A PHILIPS TECHNICAL CONSULTANT (TC) WAS DISPATCHED ONSITE TO LOOK INTO THE MATTER. THE TC FOUND ALL MONITORING WAS FULLY RESTORED FROM THE REBOOT. THE TC DECIDED TO SHUT THE PORT DOWN UNTIL SFP COULD BE REPLACED. AN INCOMPATIBLE SFP MODULE WAS FOUND IN USE, ALONG WITH A DEFECTIVE FIBER STRAND WITHIN THE HOSPITAL BACKBONE. THE SFP WAS REPLACED, AND THE CONNECTION WAS MOVED TO A VERIFIED FACILITY FIBER PAIR. HEALTH CHECK PERFORMED TO IDENTIFY OTHER POTENTIAL ISSUES THAT NEED ATTENTION. THE TC WALKED ALL THE NETWORK CLOSETS WITH BIOMED AND GATHERED THE RELEVANT LOGS. THE TC DID ANOTHER WALKTHROUGH WITH BIOMED AND FOUND TWO UPLINKS ON THE DISTRIBUTION SWITCHES TO THE ACCESS SWITCH WERE DISABLED. THE TC CONSOLED INTO THE DISTRIBUTION SWITCHES AND RAN THE COMMAND SHUT/NO SHUT ON THE TWO DISABLED PORTS, THIS DID NOT RESOLVE THE ISSUE. THE TC RAN A PABLO SCAN AND ESCALATED THE CASE TO NSS. THE TC THIS TIME CONSOLED INTO THE ACCESS SWITCH AND RAN THE SHUT/NO SHUT COMMAND ON THE TWO DISABLED PORTS AND THE ISSUE WAS RESOLVED. THE PATIENT MONITORING HAD GONE DOWN HOSPITAL WIDE AGAIN THE PREVIOUS NIGHT; THEREFORE, THE TC RETURNED ONSITE TO CONDUCT A WALKTHROUGH WITH UPMC PINNACLE LEADERSHIP. A PHILIPS PRESENCE WAS REQUESTED, AND THE TC DOCUMENTED SILVER SYNC NUMBERS IN EACH CLOSET, DOCUMENT SWITCH MODEL NUMBERS AND QUANTITY IN EACH CLOSET ALONG WITH CLOSET NAMES AND LOCATIONS. A PABLO SCAN WAS GRABBED AND ANOTHER HEALTH CHECK PERFORMED. THE UNIT HAS CONTINUED WITH NORMAL SERVICE DELIVERY SINCE THE FIX OF THE TWO DISABLED PORTS IN THE ACCESS SWITCH AREA. THE ORIGINAL ISSUE HAS NOT RESURFACED AND SYSTEM HAS BEEN STABLE. BASED ON THE INFORMATION AVAILABLE IN THE CASE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS CONFIRMED TO BE THE ACCESS SWITCH IN RELATION TO THE TWO DISABLED PORTS. THE REPORTED PROBLEM WAS CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) INTERVIEWED THE CUSTOMER AND ASSISTED THEM WITH TROUBLESHOOTING STEPS. THE CUSTOMER STATED THERE WAS NO POWER INTERRUPTION WHEN THE ISSUE OCCURRED. THE RSE INDICATED THERE WAS A MALFUNCTION ON CISCO SWITCHES AND THIS WAS A HOSPITAL-WIDE ISSUE. THE RSE RECOMMENDED REBOOTING THE UNIT TO RESOLVE THIS ISSUE. A TECHNICAL SUPPORT NETWORK ENGINEER (TSNE) WAS CONTACTED REGARDING THIS ISSUE AND USED PHILIPS REMOTE SERVICES (PRS) TO CHECK THE DEVICES STATUS AND FOUND SEVERAL SWITCHES OFFLINE AND SERVERS OFFLINE. THESE FINDINGS ALONG WITH OTHER INFORMATION WERE RELAYED TO A NATIONAL SUPPORT SPECIALIST (NSS) AND A ROOT CAUSE ANALYSIS (RCA) WAS CONDUCTED. AFTER REVIEWING LOGS, IT WAS DISCOVERED THERE WAS A DAMAGED SMALL FORM-FACTOR PLUGGABLE (SFP) OR FIBER PATCH/RUN ON CORE B PORT GI1/0/9 CAUSING THRESHOLD VIOLATIONS AND PORT FLAPPING LEAD TO EXTENSIVE SHIELDED TWISTED PAIR (STP) RECONVERGENCE AND ERR-DISABLED TRUNKS. A PHILIPS TECHNICAL CONSULTANT (TC) WAS DISPATCHED ONSITE TO LOOK INTO THE MATTER. THE TC FOUND ALL MONITORING WAS FULLY RESTORED FROM THE REBOOT. THE TC DECIDED TO SHUT THE PORT DOWN UNTIL SFP COULD BE REPLACED. AN INCOMPATIBLE SFP MODULE WAS FOUND IN USE, ALONG WITH A DEFECTIVE FIBER STRAND WITHIN THE HOSPITAL BACKBONE. THE SFP WAS REPLACED, AND THE CONNECTION WAS MOVED TO A VERIFIED FACILITY FIBER PAIR. HEALTH CHECK PERFORMED TO IDENTIFY OTHER POTENTIAL ISSUES THAT NEED ATTENTION. THE TC WALKED ALL THE NETWORK CLOSETS WITH BIOMED AND GATHERED THE RELEVANT LOGS. THE TC DID ANOTHER WALK THROUGH WITH BIOMED AND FOUND TWO UP LINKS ON THE DISTRIBUTION SWITCHES TO THE ACCESS SWITCH WERE DISABLED. THE TC CONSOLED INTO THE DISTRIBUTION SWITCHES AND RAN THE COMMAND SHUT/NO SHUT ON THE TWO DISABLED PORTS, THIS DID NOT RESOLVE THE ISSUE. THE TC RAN A PABLO SCAN AND ESCALATED THE CASE TO NSS. THE TC THIS TIME CONSOLED INTO THE ACCESS SWITCH AND RAN THE SHUT/NO SHUT COMMAND ON THE TWO DISABLED PORTS AND THE ISSUE WAS RESOLVED. THE PATIENT MONITORING WENT DOWN HOSPITAL WIDE AGAIN THE PREVIOUS NIGHT; THEREFORE, THE TC RETURNED ONSITE TO CONDUCT A WALK THROUGH WITH UPMC PINNACLE LEADERSHIP. A PHILIPS PRESENCE WAS REQUESTED, AND THE TC DOCUMENTED SILVER SYNC NUMBERS IN EACH CLOSET, DOCUMENT SWITCH MODEL NUMBERS AND QUANTITY IN EACH CLOSET ALONG WITH CLOSET NAMES AND LOCATIONS. ANOTHER PABLO SCAN WAS GRABBED. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT MULTIPLE SURVEILLANCE CENTRAL STATIONS WERE DOWN AND NOT ABLE TO MONITOR A PATIENTS AND IT WAS HOSPITAL WIDE ISSUE. 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
    106868 PATIENT INFORMATION CENTER IX MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX C.03.10 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1