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	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on a patient information center ix indicating that three central stations were not producing audible alarm sounds.The device was reported to be in clinical use.No adverse event to the patient or user was reported.
Additional Manufacturer Narrative
Analysis was performed by remote service personnel which included troubleshooting.The customer was instructed to have biomed verify the physical connections associated with the affected central stations, including the speaker and ethernet cable connections.During inspection, biomed identified that the ethernet cables for the three central stations were unplugged from the wall jack ports.Once the ethernet cables were reconnected to the appropriate wall jack ports, alarm audio functionality was immediately restored on all three central stations.The biomed indicated they don't know the reason why the speaker ethernet cable was unplugged.Based on the results of the analysis, the product was confirmed to be operating per specifications and the cause of the reported problem was the ethernet cables for the three central stations were disconnected from the wall jack ports, preventing alarm audio from being transmitted.The issue was resolved by reconnecting the ethernet cables to the appropriate wall jack ports, and the product is back in service.Alarm sounds were restored and verified to be functioning as expected, and biomed confirmed that the issue was resolved.

• 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: 50668845
• Report Number: 1218950-2026-100610
• Device Sequence Number: 10153472
• Product Code: MHX
• UDI-Device Identifier: 00884838093041
• UDI-Public: (01)00884838093041(10)C.03.04
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 09/08/2026

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2021
• 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