MAUDE Adverse Event Report: Philips Medizin Systeme Böblingen GmbH Patient Information Center iX

Model Number	Patient Information Center iX
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis performed: analysis was performed by remote service personnel and included review of available log files, patient records, alarm settings, investigation of patient mrns associated with transfers/admissions, follow-up discussions with the customer, and efforts to reproduce the reported alarm behavior.The results of the analysis were that the reported alarm behavior could not be replicated or definitively confirmed from the available log data.Alarm settings were verified as enabled for the patients reviewed, and no evidence was found that alarms had been turned off.The customer indicated that the issue was observed when patients were transferred to ward 7c and assigned an mx40 telemetry device; however, insufficient event-specific information was available to confirm the reported malfunction.Based on the results of the analysis, the product malfunction was unable to be confirmed.As a precautionary measure, no corrective action was implemented because no product-related issue could be identified.The customer was instructed to document the date, time, and bed label of any future occurrence to support further investigation, and the system remained in service and was confirmed to be operating according to specifications.A review of the service activities associated with this investigation did not identify evidence of the reported issue recurring within the available information reviewed.(b)(6).
Event or Problem Description
It was reported that alarms turned off in ward c.The device was in clinical use.There was no report of patient or user harm.

• Brand Name: Patient Information Center iX
• Common Device Name: Patient Information Center iX
• 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: 50880418
• Report Number: 9610816-2026-102005
• Device Sequence Number: 21272770
• Product Code: MHX
• UDI-Device Identifier: 00884838122772
• UDI-Public: (01)00884838122772(10)4.3.7.0
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 09/24/2026

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: 09/01/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2025
• 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