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	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on a patient information center ix indicating that following a network failure at the hospital, the philips monitoring systems were unable to resume all functions automatically after the network was restored.The bed-to-bed overview and alarm forwarding were only reactivated automatically in the medical intensive care unit and the intermediate care unit.In all other stations with philips monitoring, this had to be manually activated in the pic ix system configuration.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 remote service personnel which included remotely checking the system configuration.The results of the analysis indicate the auto reconnect setting was deactivated on some of the control units.Based on the results of the analysis, the product was confirmed to be operating per specifications, and the cause of the reported problem was the configuration to auto reconnect was deactivated on some of the control units, causing them to remain in local mode and requiring manual reconnection.The issue was resolved by activating the auto reconnect function in configuration.A review of the service history for this device shows the problem has not been reported again for this device.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: 50223973
• Report Number: 9610816-2026-101651
• Device Sequence Number: 5432821
• Product Code: MHX
• UDI-Device Identifier: 00884838128880
• UDI-Public: (01)00884838128880(10)4.6.2
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 08/12/2026

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: 08/05/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2026
• 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