MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	PATIENT INFORMATION CENTER IX
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.E1: reporting institution phone #: (b)(6).Reporter phone #:.
Event or Problem Description
Philips received a complaint on a patient information center ix (pic ix) indicating that from 8:00 a.M.To 10:00 a.M., incorrect data was transmitted from the central monitoring station to bed in1-01 on ward hf-its1.One example was systolic blood pressure: the central station measured a value of 95 mmhg, while the icca measured 145 mmhg.This value can influence decisions regarding the patient¿s treatment.The customer looked into the problem and determined that incorrect data is contained in the obx messages.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.
Additional Manufacturer Narrative
The customer reported that incorrect data was transmitted from the central monitoring station to the icca after a recent go-live.Retrospective data is used in conjunction with clinical evaluation of the patient and other assessment data (weight, urine output etc.) to make treatment decisions for the patient.The incorrect representation of retrospective data, in regard to regional level display, would not be likely to cause or contribute to harm.The inability to edit retrospective data would be identified by the user at the time the issue is noted.Stored data is not used exclusively to make clinical treatment decisions for patient care.Based on this information the malfunction did not cause or contribute to death or serious injury and is not likely to cause or contribute to death or serious injury if it were to recur.Therefore, this is not reportable.

• Brand Name: PATIENT INFORMATION CENTER IX
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• 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: 25201446
• Report Number: 1218950-2026-100330
• Device Sequence Number: 10096922
• Product Code: MHX
• UDI-Device Identifier: 00884838048645
• UDI-Public: (01)00884838048645(10)B.02.17
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K153702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2019
• 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