MAUDE Adverse Event Report: Philips Medical Systems Patient Information Center IX; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Model Number	Patient Information Center iX
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An analysis was performed by a philips technical consultant (tc) which included direct observation of the device in the reported failure.The tc observed that the patient information center ix workstation sectors remained frozen, with the application repeatedly crashing and the computer restarting in a continuous loop.The tc performed several hard reboots, reloaded the operating system and application using the c.03.09 media kit, patched the system to c.03.10, and restored the archive file.After these actions, the sectors again froze after approximately five minutes of operation.Following another hard reboot, the application launched successfully and the sectors appeared to function normally with stable measurement readings.The tc recommended replacement of the workstation hard drive as a precautionary measure as it is uncommon for this issue to return immediately after a media kit reload.Based on the results of the analysis, it was determined that the product has malfunctioned and the most likely cause of the reported problem was a possible hard drive issue, but this was not confirmed.A follow-up work order was planned to replace the hard drive.In a subsequent follow-up, the onsite biomed confirmed that no further application freezes had been reported.
Event or Problem Description
It was reported that the device is freezing and the waveforms stop updating.The device was in use on a patient at the time of the event.There was no adverse event reported.

• Brand Name: Patient Information Center IX
• Common Device Name: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
• 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: 50480006
• Report Number: 1218950-2026-100587
• Device Sequence Number: 10203508
• Product Code: MHX
• UDI-Device Identifier: 00884838093041
• UDI-Public: (01)00884838093041(10)C.03.10
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/27/2026

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: 08/04/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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