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

Model Number	Patient Information Center iX
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the audible alarms reset without user intervention.The device was in clinical use.There was no report of patient or user harm.
Additional Manufacturer Narrative
Analysis was performed by remote service personnel which included review of the customer-reported issue, clinical audit trail review, software version verification, troubleshooting of alarm behavior, and follow-up investigation with biomed personnel.The results of the analysis were that no error codes were present, alarms were found to be generated and acknowledged from remote locations, and no software or application malfunction was identified.Further investigation determined that the audible alarm issue was isolated to the pic ix surveillance external speaker.Biomed reported that audible alarm tones would stop when the speaker was bumped or disturbed, while alarm banners continued to display normally.Based on the results of the analysis, it was determined that the product malfunctioned and the most likely cause of the reported problem was an intermittent failure of the external surveillance speaker, resulting in loss of audible alarm tones while visual alarm functionality remained intact.The issue was resolved by replacing the pic ix surveillance external speaker, and the product was confirmed to be functioning as intended and returned to service after verification that alarm sounds and tones were operating normally.

• 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: 50786254
• Report Number: 9610816-2026-101918
• Device Sequence Number: 10571284
• Product Code: MHX
• UDI-Device Identifier: 00884838127067
• UDI-Public: (01)00884838127067(10)4.4.5
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/16/2026

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: 08/23/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2026
• 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