MAUDE Adverse Event Report: Philips Medizin Systeme Böblingen GmbH IntelliVue Multi-Measurement Module X3

Model Number	IntelliVue X3
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the diastolic blood pressure reading is high.The device was not in clinical use.There was no report of patient or user harm.
Additional Manufacturer Narrative
Analysis was performed by onsite service personnel which included replication of the reported high/out-of-tolerance nbp reading, review of calibration test results, troubleshooting of the nbp subsystem and performance verification testing.He results of the analysis confirmed that the reported issue could be reproduced and that the nbp module was the source of the out-of-tolerance readings observed during calibration testing.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 nbp pump assembly.The issue was resolved by replacing the defective part.Following replacement, the device successfully passed nbp calibration, the full preventive maintenance (pm) procedure, and electrical safety testing (est), confirming that the corrective action restored normal operation.A review of the service history for this device shows that the issue was corrected through replacement of the nbp module and no subsequent recurrence was identified following verification testing and return to service.E1: reporting institution phone#: (b)(6).E1: reporter phone#: (b)(6).

• Brand Name: IntelliVue Multi-Measurement Module X3
• Common Device Name: IntelliVue Multi-Measurement Module X3
• 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: 50814398
• Report Number: 9610816-2026-101938
• Device Sequence Number: 10697005
• Product Code: MHX
• UDI-Device Identifier: 00884838082588
• UDI-Public: (01)00884838082588
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K171801
• 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): 09/18/2026

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: IntelliVue X3
• Device Catalogue Number: 867030
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2022
• 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