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	07/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on a patient information center ix which indicated wireless telemetry is not visible on the central monitor in several units hospital wide although hard-wired monitors are visible.The device was in use on a patient at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
Analysis was performed by onsite service personnel which included functional testing and troubleshooting.The results of the analysis confirmed the issue and identified that on the customer side; a switch was down.Based on the results of the analysis, it was determined that the product has malfunctioned and the most likely cause of the reported problem was a switch that was down on the customer side of the network.The issue was resolved by plugging the uninterrupted power supply (ups) back in.The system was checked after bringing it back up and found to be resolved.The product is back in service.Based on the information available and results of additional analysis, no further action is necessary at this time.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 ; +49(703)14632031
• MDR Report Key: 50161931
• Report Number: 9610816-2026-101603
• Device Sequence Number: 18196868
• Product Code: MHX
• UDI-Device Identifier: 00884838128880
• UDI-Public: (01)00884838128880(10)4.6.1.0
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/06/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2026
• Initial Report FDA Received Date: 08/06/2026
• 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
• Patient Sex: Unknown