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	04/16/2026
Type of Reportable Event	Death
Event or Problem Description
The client contacted us following a case of death in the (b)(6) department related to a patient disconnection whose alarm would not have sounded.The patient was found lifeless and disconnected.A log analysis was requested to find out if the alarms sounded and potentially seen by the caregivers.
Additional Manufacturer Narrative
A philips remote service engineer (rse) reviewed the clinical audit logs and found that the technical leads off ecg alarm went off at 16:38 and was present until 18:33.The alarm was silenced at 17:46 at the central station.A response was sent by email to the customer.The complaint was escalated for a technical complaint investigation (product support engineering reviewed the clinical audit logs).The clinical audit logs indicate that there was an alarm that was silenced at 16:38.The alarm was silenced again after the ecg leads were off at 17:46.Then at 18:33, the equipment was offline, this could mean the mx40 was not monitoring the patient as ecg leads were off at that time.If the equipment is offline, there will not be a sound from the pic ix.See excerpt of logs below: (b)(6) 2026, 16:38:28 ch19 silence silence, picixusic/ (b)(6) 2026, 16:38:29 ch19 silence silence, picixusic/ (b)(6) 2026, 16:38:30, ch19, silence silence, picixusic/ (b)(6) 2026, 16:39:43, ch19, ecg leads off generated at 16:39:43.Piic ix: picixusic/ (b)(6) 2026, 16:39:46, ch19, ecg leads off generated at 16:39:46.Piic ix: picixusic/ (b)(6) 2026, 16:39:47, ch19, ecg leads off ended.Piic ix: picixusic/ (b)(6) 2026, 17:46:40, ch19, silence, picixusic/ (b)(6) 2026, 18:33:10, ch19, offline equipment, mx40-12/ (b)(6) 2026, 18:33:11, ch19, ecg leads off ended, piic ix: picixusic/ (b)(6) 2026, 18:34:46, ch19, equipment on standby, mx40-12.The rfda (wireless) logs indicate the device lost association from the pic ix, which could be attributed to the battery removal.Nothing in the logs indicate a wireless problem at the time.18:33:10.978 / (b)(6) 2026: rfassocmgr - device with lbn (5) monitor(mx40-12) timed out during monitoring stage - aborting device.18:33:10.978 / (b)(6) 2026: rfassocmgr - central sending abort message to lbn (5) monitor(mx40-12).18:34:46.594 / (b)(6) 2026: device (mx40-12) entering standby.Based on the results of the analysis, the product was confirmed to be operating as designed, operated, and configured.The investigation concludes that no further action is required at this time.Section e: 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 ; 6172455900
• MDR Report Key: 25410787
• Report Number: 1218950-2026-100373
• Device Sequence Number: 10311165
• Product Code: MHX
• UDI-Device Identifier: 00884838048645
• UDI-Public: (01)00884838048645(10)B.02.18
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 06/05/2026

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: 05/08/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2020
• 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