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	Defective Alarm (1014)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/05/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported the customer 'missed an alarm' but did not know which alarm or from which device.The patient passed away.The customer requested assistance determining whether the alarm occurred or not.No other clinical information or medical intervention was reported; therefore, good faith efforts are being performed.
Additional Manufacturer Narrative
E1: reporting institution phone #: (b)(6).Logs were provided; however, no additional information was provided.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
No analysis was performed by philips, however despite repeated attempts no additional information was provided.Without information concerning the bed label, date and time of the event and missed alarm, no investigation can be performed.The product malfunction was unable to be confirmed because the customer did not respond to requests for additional information.A review of the service history for this device shows no activity which confirm the problem has not been reported again for this device.If additional information is received, the complaint file will be reopened for further investigation.

• 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 ; 6172455900
• MDR Report Key: 23738809
• Report Number: 1218950-2025-000721
• Device Sequence Number: 8460490
• Product Code: MHX
• UDI-Device Identifier: 00884838048645
• UDI-Public: (01)00884838048645(10)B.02.13
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K153702
• 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): 01/21/2026

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?: 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2023
• 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