MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 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	06/08/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported the emergency department staff did not hear the red alarm sounds and there was delay in care for the patient.The patient subsequently passed away.The customer biomedical engineer (biomed) indicated the emergency room (er) surveillance station volume level defaults are all the same; however, the external speaker audio output differs between stations.The customer requested assistance in confirming the monitors were functioning as specified.
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke to the customer; the customer requested onsite service.A philips technical consultant (tc) went to the customer site and indicated that the units were alarming correctly, and the customer would like to get clinical support to set default minimum alarm levels to the same for all ed computers.No further information was provided by the customer on the patient and cause of death.The tc was able to provide an audit log, which shows that the device was alarming for the spo2 sensor being off before and after 13:30 for bed 19.On (b)(6) 2026 13:30:20, college station, ed-19, sector: spo2, sensor off ended.Pic ix: cshphcedovr02.On (b)(6) 2026 13:30:16, college station, ed-19, sector: spo2, sensor off ended.Pic ix: cshphcedsrv01.On (b)(6) 2026 13:30:23, college station, ed-19, sector: spo2, sensor off ended.Pic ix: cshphcedovr01.On (b)(6) 2026 13:30:16, college station, ed-19, spo2 sensor, off ended.Cshedmon19.On (b)(6) 2026 13:29:59, college station, ed-19, sector: spo2, sensor off generated at 13:29:55.Pic ix: cshphcedsrv01.On (b)(6) 2026 13:30:02, college station, ed-19, sector: spo2, sensor off generated at 13:29:55.Pic ix: cshphcedovr02.On (b)(6) 2026 13:30:05, college station, ed-19, sector: spo2, sensor off generated at 13:29:55.Pic ix: cshphcedovr01.On (b)(6) 2026 13:29:59, college station, ed-19, spo2 sensor, off generated at 13:29:55.Cshedmon19.On (b)(6) 2026 13:29:57, college station, ed-19, sector: spo2, sensor off ended.Pic ix: cshphcedovr02.On (b)(6) 2026 13:29:54 college station, ed-19, sector: spo2, sensor off ended.Pic ix: cshphcedsrv01.On (b)(6) 2026 13:30:00 college station, ed-19, sector: spo2, sensor off ended.Pic ix: cshphcedovr01.On (b)(6) 2026 13:29:53, college station, ed-19, spo,2 sensor off ended.Cshedmon19 on (b)(6) 2026 13:29:50, college station, ed-19, sector: spo2, sensor off generated at 13:29:46.Pic ix: cshphcedsrv01.On (b)(6) 2026 13:29:56, college station, ed-19, sector: spo2, sensor off generated at 13:29:46.Pic ix: cshphcedovr01.On (b)(6) 2026 13:29:53, college station, ed-19, sector: spo2, sensor off generated at 13:29:46.Pic ix: cshphcedovr02.On (b)(6) 2026 13:29:49, college station, ed-19, spo2, sensor off generated at 13:29:46.Cshedmon19.On (b)(6) 2026 13:29:48, college station, ed-19, sector: spo2, sensor off ended.Pic ix: cshphcedovr02.On (b)(6) 2026 13:29:45, college station, ed-19, sector: spo2, sensor off ended.Pic ix: cshphcedsrv01.On (b)(6) 2026 13:29:51, college station, ed-19, sector: spo2, sensor off ended.Pic ix: cshphcedovr01.On (b)(6) 2026 13:29:44, college station, ed-19, spo2, sensor off ended.Cshedmon19 on (b)(6) 2026 13:29:47, college station, ed-19, sector: spo2, sensor off generated at 13:29:36.Pic ix: cshphcedovr01.On (b)(6) 2026 13:29:41, college station, ed-19, sector: spo2, sensor off generated at 13:29:36.Pic ix: cshphcedsrv01.Based on the results of the analysis, the product was confirmed to be operating per specifications and the cause of the reported problem was related to user alarm level configuration.Based on the information available and results of additional analysis, no further action is necessary at this time.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.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 MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 25666575
• Report Number: 9610816-2026-101266
• Device Sequence Number: 5701589
• Product Code: MHX
• UDI-Device Identifier: 00884838128880
• UDI-Public: (01)00884838128880(10)4.6.1.0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K211900
• 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): 06/30/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2026
• 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