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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/04/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that there was a patient death, and the user requested an export of the clinical audit trail.The audit trail indicated that the device was working as intended and alarms were delivered.No other clinical information or medical intervention was reported; therefore, good faith efforts are being performed.
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.Reporting institution phone # (b)(6).Reporter phone # (b)(6).

• 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: 50933055
• Report Number: 1218950-2026-100671
• Device Sequence Number: 10759765
• Product Code: MHX
• UDI-Device Identifier: 00884838093041
• UDI-Public: (01)00884838093041(10)C.03.10
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/29/2026
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown