MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH PATIENT INFORMATION CENTER IX; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	4.5
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips field service engineer (fse) went to the customer site and verified saturation of the ip addresses distributed by the access point controller.The fse purged and verified that the system had resumed proper operation.Fault tracing was performed to determine the cause.The fse fixed the ip address configured on all bedside monitors, except for utic 6 and cardio bed 11, which were not accessible.The fse changed dynamic host configuration protocol (dhcp) scope on the server and isolated the problem on the xds monitor network adapter in emergency medicine, which distributed the ip address abnormally.The fse restored the correct operation of the device and verified behavior of the whole system, which was regular.No further problems were found.The system was left ready for clinical use.Based on the information available and the testing conducted, the cause of the reported problem was related to an xds monitor network adaptor issue with the ip address.The reported problem was confirmed.The device was operational after repairs were completed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.E1: reporting institution phone #: (b)(6).Repoter phone #: (b)(6).
Event or Problem Description
Philips received a complaint on a patient information center ix (pic ix) indicating that all telemetry signals were lost.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm 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: 23794599
• Report Number: 9610816-2025-001213
• Device Sequence Number: 18777681
• Product Code: MHX
• UDI-Device Identifier: 00884838127074
• UDI-Public: (01)00884838127074(10)4.5
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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: 4.5
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2025
• 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