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

Model Number	PATIENT INFORMATION CENTER IX
Medical Device Problem Codes	Communication or Transmission Problem (2896); Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported all monitors were no longer displayed with inoperative messages appearing on the screen "lan not supported" and "no data monitor".The device was in use on a patient at the time of the event, there was no adverse event reported.
Additional Manufacturer Narrative
E1: reporter institution phone number: (b)(6).E1: reporter phone number: a philips remote service engineer (rse) interviewed the customer who reported the connected monitors no longer received an ip address and could not connect to the central station.The error occurred with several monitors, and the switch was restarted without success.The rse had the customer check the cable connections, which showed available.The rse recommended the customer restart the central station and immediately they received a valid ip address.The connection to the central station was successfully established and no further error messages were visible.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.
Additional Manufacturer Narrative
A philips remote service engineer (rse) interviewed the customer who reported the connected monitors no longer received an ip address and could not connect to the central station.The error occurred with several monitors, and the switch was restarted without success.The rse had the customer check the cable connections, which showed available.The rse recommended the customer restart the central station and immediately they received a valid ip address.The connection to the central station was successfully established and no further error messages were visible.The rse suggested the root cause of the issue was probably a temporary connection or service error of the control panel.A good faith effort (gfe) response noted the nature of the issue was a that of a hospital supplied network and not a philips supplied network where there was only one affected clinical unit.Based on the information available, the cause of the reported problem was not confirmed.The reported problem was confirmed.If additional information is received the complaint file will be reopened.The unit was operational after the customer rebooted system and returned to working specification.If additional information is received the complaint file will be reopened.No further investigation or action is warranted at this time.Additional information was received by a good faith effort (gfe) response that identified this issue as a hospital supplied network.As per the definition of non-reportable, the absence or loss of network connectivity would be associated with obvious indicators that data transmission is not occurring.Bedside monitors alarm and display a no central monitoring inop message; mx40s enter monitor mode, alarm locally and display a no central monit.Message; trx4841a/trx4851a transceivers generate a beep sound to indicate that there is no central monitoring.The user is instructed to implement alternate means of monitoring as warranted.

• 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: 23296413
• Report Number: 1218950-2025-000598
• Device Sequence Number: 4889639
• Product Code: MHX
• UDI-Device Identifier: 00884838086715
• UDI-Public: (01)00884838086715(10)C.02.03
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K163584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

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: PATIENT INFORMATION CENTER IX
• Device Catalogue Number: 866389
• Device Lot Number: C.02.03
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2019
• 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