MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX

Model Number	PATIENT INFORMATION CENTER IX
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis was performed by remote service personnel which included communication with the customer.It was clarified that the customer was not alleging a failure of the device but was inquiring if pvcs should be detected by the philips monitor.It was confirmed that the system was functioning as designed and configured.Based on the results of the information available, the product was confirmed to be operating per specifications, and the cause of the reported problem was the monitor was not configured to alarm for arrhythmia.The customer was provided the information they requested regarding the normal function of the alarms and configurations.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.This complaint is a supplemental to 9610816-2026-100648 due to incorrect registration number used.
Event or Problem Description
Philips received a complaint on a patient information center ix indicating that the monitor is not alarming as expected for premature ventricular contractions (pvc).The device was in use on a patient at time of event, there was no adverse event reported.

• Brand Name: PATIENT INFORMATION CENTER IX
• Common Device Name: PATIENT INFORMATION CENTER IX
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 25016202
• Report Number: 1218950-2026-100263
• Device Sequence Number: 18570311
• Product Code: MHX
• UDI-Device Identifier: 00884838086715
• UDI-Public: (01)00884838086715(10)C.02.03
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K163584
• 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): 04/28/2026

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?: Yes
• Initial Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2019
• 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