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	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a complaint on a patient information center ix indicating that the customer is requesting a log review for a reboot issue which occurred for mx800 / x2/ etco2 & piicix.It was reported this issue occurred for 8 minutes while the patient coded.No other clinical information or medical intervention was reported, however it was confirmed the patient is fine.
Additional Manufacturer Narrative
Customer is requesting a tc onsite to view the logs and investigate the reboot issue for mx800 / x2/ etco2 & piicix that happened for 8 minutes while the patient coded in building (b)(6) between 9:20 & 9:30am.Analysis and testing was performed by the philips technical consultant (tc) went to the customer site to further evaluate the situation.The tc checked the logs and found that the monitor never turned off.It was placed on standby.The logs showed that the monitor is alarming the whole time the patient was coding.The alarms from building (b)(6) between 9:20 & 9:30am showed that there was several alarms for apnea, tachy, vtach and they were acknowledged by staff.Based on the review of the logs, the device was performing per specification, and the most likely cause of the reported problem is unknown as it was not replicated.The device was tested by the tc and passed specifications and put back into use at customer site.

• 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: 24202854
• Report Number: 9610816-2026-100155
• Device Sequence Number: 21238799
• Product Code: MHX
• UDI-Device Identifier: 00884838104594
• UDI-Public: (01)00884838104594(10)4.0
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/28/2026

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: 12/30/2025
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2023
• 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: Other
• Patient Sex: Unknown