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	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis was performed remote service personnel.The remote support engineer (rse) talked to the customer and advised live tests on the reported device.The results of the analysis were that there was no more sound and the multi speaker rack needs replacement.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 defective multi speaker rack.The issue was resolved by sending a replacement part part to the customer who will perform the repair.A review of the service history for this device shows the problem has not been reported again for this device.E1: reporting institution phone#: (b)(6).
Event or Problem Description
It was reported there was no more sound on the central station screen.The device was not 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 ; 70314632031
• MDR Report Key: 24426950
• Report Number: 9610816-2026-100373
• Device Sequence Number: 20908019
• Product Code: MHX
• UDI-Device Identifier: 00884838127074
• UDI-Public: (01)00884838127074(10)4.5.1.0
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/24/2026

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: Other
• Device Model Number: PATIENT INFORMATION CENTER IX
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2025
• 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