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

Model Number	Patient Information Center iX
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the alarm text is displayed but there is no audible alarm.The device was in clinical use.There was no report of patient or user harm.
Additional Manufacturer Narrative
Analysis was performed by remote service personnel which included review of the reported issue, troubleshooting efforts to reproduce the problem, verification of system configuration settings, and review of service documentation.The reported issue was that alarm text was displayed at surveillance station bjhix63sur1, however, no alarm audio was heard.The issue was reproducible.Investigation confirmed that the external speaker was properly connected and had been replaced by the customer without resolving the issue.Further troubleshooting identified that the sound output in the control panel was incorrectly configured to the hrt receiver instead of the external speaker.No error codes or error messages were reported.Software version c.03.06 was installed at the time of the event.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 a configuration issue in the audio output settings.The issue was resolved by reconfiguring the sound output in the control panel to the external speaker.Following the configuration change, the customer verified that alarm audio was functioning correctly and alarms could be heard at the surveillance station.The system met specifications following service and was returned to use.

• 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: 50865600
• Report Number: 1218950-2026-100656
• Device Sequence Number: 18810011
• Product Code: MHX
• UDI-Device Identifier: 00884838093041
• UDI-Public: (01)00884838093041(10)C.03.10
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/23/2026

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: 08/26/2026
• Initial Report FDA Received Date: 09/23/2026
• 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