MAUDE Adverse Event Report: Philips Medizin Systeme Böblingen GmbH Patient Information Center iX; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Model Number	4.6
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that that the central station is not communicating with bedside monitors.The device was in use on a patient at the time of the event.There was no adverse event reported.
Additional Manufacturer Narrative
An analysis was performed by a philips remote service engineer (rse).The analysis included remote login to the primary server to verify the hostname of the central station, checking device status, and identifying that there was an offline switch.The customer biomed was asked to locate the switch but was unable to do so.Further consultation with a philips network engineer did not resolve the issue, as the switch to which the two down central stations were connected could not be traced.A philips field service engineer (fse) was scheduled to do additional investigation.The fse confirmed that no patient data was showing on the monitor, the device was showing an unsupported lan, no data tele inops and no hl7 electronic charting yellow banner.Additional onsite investigation revealed that work was ongoing in the 6th-floor intermediate distribution frame (idf) closet, with cables unplugged or plugged into different vlans, and numerous unlabeled cables present.No fix was implemented at the time of investigation, as it was determined that the installers needed to continue their work in the 6w closet.It was unclear if the work was being completed by philips or a 3rd party and the biomed did not know.Based on the results of the analysis, the product was confirmed to be operating per specifications, and the cause of the reported problem was ongoing work on the customer network.It is unknown how the issue was resolved as the customer has not provided any additional information regarding the completion of the work.

• 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: 50453796
• Report Number: 9610816-2026-101736
• Device Sequence Number: 15912141
• Product Code: MHX
• UDI-Device Identifier: 00884838128880
• UDI-Public: (01)00884838128880(10)4.6.2
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/26/2026

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: 4.6
• 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: 07/30/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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