MAUDE Adverse Event Report: Philips Medical Systems Patient Information Center iX

Model Number	Patient Information Center iX
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that telemetry devices do not connect to pic ix computers.The device was in clinical use.There was no report of patient or user harm.
Additional Manufacturer Narrative
Analysis was performed by onsite service personnel which included reproduction of the reported issue in the affected care areas, review of the reported "no data tele" error condition, testing of affected wireless access points across multiple apcs, execution of the upgrader service tool, and review of system connectivity behavior.The results of the analysis showed that no device or pic ix software faults were identified.Testing confirmed that the mx40 telemetry transmitters were obtaining a default ip address and connecting to the nearest access point; however, customer network configuration settings prevented proper communication with the pic ix system.Based on the results of the analysis, the product was confirmed to be operating per specifications, and the cause of the reported problem was determined to be customer network configuration issues, specifically authentication and dhcp snooping settings within the customer's infrastructure.The issue was resolved by the customer reconfiguring the access point controller apc1 and apc2 network ports, removing auth, 802.1x (dot1x), and ise settings, and enabling dhcp snooping trust.Successful operation was verified by rebooting and testing mx40 transmitters on all affected floors, with telemetry connectivity restored in each location and confirmed by biomed personnel.A review of the service activities associated with this event confirmed that the issue was resolved following the network configuration changes and no subsequent recurrence was reported during verification testing.

• Brand Name: Patient Information Center iX
• Common Device Name: Patient Information Center iX
• Manufacturer (Section D): Philips Medical Systems; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): Philips Medical Systems; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; +1(617)245-5900
• MDR Report Key: 50803959
• Report Number: 1218950-2026-100639
• Device Sequence Number: 8597391
• Product Code: MHX
• UDI-Device Identifier: 00884838093041
• UDI-Public: (01)00884838093041(10)C.03.10
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K183387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: Patient Information Center iX
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown