MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH PATIENT INFORMATION CENTER IX; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	PATIENT INFORMATION CENTER IX
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips remote service engineer (rse) contacted the customer.The rse reviewed audit trail, and no deviations could be detected in the log files of the event notification.The red alarms from the period from (b)(6) 2026 were all delivered to the careassist app end device, but the user did not respond via the app.Based on the results of the analysis, the product was confirmed to be operating per specifications.The rse provided the findings to the customer.A review of the service history for this device shows the problem has not been reported again for this device.Reporting institution phone # (b)(6).
Event or Problem Description
It was reported that red alarms have not been received on the logged in mobile devices running careassist.The device was in use on a patient at the time of the event.There was no adverse event reported.

• 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 ; 70314632031
• MDR Report Key: 24390406
• Report Number: 9610816-2026-100332
• Device Sequence Number: 13403700
• Product Code: MHX
• UDI-Device Identifier: 00884838121782
• UDI-Public: (01)00884838121782(10)4.4.4
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2025
• 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