MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX

Model Number	4.2
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported multiple central station hosts were in local mode.The device was in use on a patient at the time of the event, there was no adverse event reported.
Additional Manufacturer Narrative
A philips remote service engineer (rse) interviewed the customer, and they could not confirm if there was an issue with the power/network outage or not.The customer was not familiar with the system and was unable to troubleshoot on the phone to determine if this was a network or domain name system (dns) issue.Also, it was unclear if this was a philips supply collaboration network (pscn) or a customer supply collaboration network (cscn) issue.The site is on philips remote service (prs) but the central station servers were not remotely reachable.A philips technical consultant (tc) was dispatched onsite to further evaluate the unit.The tc discovered there was a network communication problem between the hosts and the primary server that impacted the physo servers.The tc determined that after adding the 10th physo to the network one of the switches was slightly overloaded.There was a band width issue on the network with the physio and primary servers.To resolve the issue, the tc created bridge connections on the phsyio servers, so that multiple nic cards on each server were connected to multiple network switches.Network paring on the newer phsyo servers was set up to support it 6-10.A good faith effort (gfe) response confirmed the customer was operating under a philips supplied network.The gfe response also noted the issue spanned the whole hospital where multiple units were affected.Based on the information available and the testing conducted, the cause of the reported problem was confirmed to be a band width issue on the network with the physio and primary servers.The reported problem was confirmed.If additional information is received the complaint file will be reopened.No further investigation or action is warranted at this time.

• 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 ; 6172455900
• MDR Report Key: 23708441
• Report Number: 1218950-2025-000718
• Device Sequence Number: 10641444
• Product Code: MHX
• UDI-Device Identifier: 00884838121782
• UDI-Public: (01)00884838121782(10)4.2.4.0
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K211900
• 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): 12/03/2025

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: 4.2
• Device Catalogue Number: 866389
• Device Lot Number: 4.2.4.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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