MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX

Model Number	PATIENT INFORMATION CENTER IX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported there was an 'inter-bedside dysfunction'.The infant patient was transferred from the neonatology department to icu on the x3 between 12-1pm.Upon arrival to the icu, the x3 was docked on the mx400 monitor.It was reported the patient had a heart attack and was intubated at 12:15pm and then stabilized.The father of the patient was present in the room and alerted the nursing staff.It was also noted ' an alarm would have sounded on the monitor and on the control panel but there would have been no bedside stop'.
Additional Manufacturer Narrative
E1: (b)(6).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.
Event or Problem Description
Philips received a complaint on the patient information center ix indicating there was an 'inter-bedside dysfunction'.The infant patient was transferred from the neonatology department to icu on the x3 between 12-1pm.Upon arrival to the icu, the x3 was docked on the mx400 monitor.It was reported the patient had a heart attack and was intubated at 12:15pm and then stabilized.The father of the patient was present in the room and alerted the nursing staff.It was also noted ' an alarm would have sounded on the monitor and on the control panel but there would have been no bedside stop'.Additional information indicated the alarm was generated at the bedside and central station; however, the staff did not hear the alarm and the father of the patient alerted nursing staff to the condition of the patient.There was no bedside overview from the monitor in the patient room.The patient was stabilized and 'ok' per biomed.Logs were returned for investigation.Based on the information received, the event was life-threatening and required medical intervention.
Additional Manufacturer Narrative
A philips field service engineer (fse) evaluated the device and could not confirm the alarm issue.The logs were reviewed and showed no signs of malfunction.The logs show that the alarm sound was playing during the corresponding event.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: PATIENT INFORMATION CENTER IX
• Common Device Name: PATIENT INFORMATION CENTER IX
• 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: 23888743
• Report Number: 1218950-2025-000765
• Device Sequence Number: 21245152
• Product Code: MHX
• UDI-Device Identifier: 00884838104594
• UDI-Public: (01)00884838104594(10)4.0.1.0
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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: 12/10/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2022
• 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: Required Intervention
• Patient Sex: Unknown