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	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips field service engineer (fse) was dispatched to the customer site.The fse logged in and monitored the system.The fse identified that the network to be rebooted.They rebooted the network host and all the mx40s began to connect and display the vitals in the sectors.Confirmed with the customer and they verified that can monitor patients.Based on the information available and the testing conducted, the likely cause of the reported problem was a network issue.The reported problem was confirmed.The network was rebooted and reconnected the mx40s to the central station.It was confirmed that all was operational per specification.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
Event or Problem Description
Philips received a complaint on the patient information center ix (pic ix) indicating that the 6th, 7th and 8th floor mx40s are not connecting to central station.The wireless telemetry is not pulling vitals.The device was in clinical use monitoring patients at time of event, no adverse event was reported.

• 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: 23923556
• Report Number: 9610816-2025-001327
• Device Sequence Number: 21090012
• Product Code: MHX
• UDI-Device Identifier: 00884838127074
• UDI-Public: (01)00884838127074(10)4.4.3.0
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 12/02/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2024
• 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
• Patient Sex: Unknown