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

Model Number	IntelliVue X3
Medical Device Problem Code	Failure to Deflate (4060)
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 the device is having issues with taking blood pressure as it keeps pumping.The device was not in clinical use.There was no report of patient or user harm.
Additional Manufacturer Narrative
Analysis was performed by remote service personnel and included review of the customer-reported nbp performance issue, remote troubleshooting, assessment of the reported symptoms, review of service documentation, and evaluation of possible causes based on information provided by the customer.The results of the analysis indicated that the nbp parameter was reportedly not functioning properly, with users reporting that blood pressure measurements frequently failed and, when successful, required an extended measurement time.The customer had already replaced the cuff and tubing; however, no additional diagnostic testing or performance verification results were available because biomed support was unavailable at the time of the investigation.No error messages were reported.Based on the results of the analysis, it was determined that the product had malfunctioned, and the most likely cause of the reported problem was a malfunction within the nbp pneumatic system, potentially involving the nbp pump assembly or an undiagnosed leak condition affecting nbp measurement performance.The issue was addressed by providing the customer with the part identification for the nbp pump assembly, forwarding the applicable service manual, and recommending completion of a full performance verification to evaluate the system for leaks and confirm proper operation.The product was subsequently reported as meeting specifications and was returned to service.

• 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: 50931736
• Report Number: 9610816-2026-102048
• Device Sequence Number: 21522336
• Product Code: MHX
• UDI-Device Identifier: 00884838082588
• UDI-Public: (01)00884838082588
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• 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