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

Model Number	IntelliVue X3
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for bench repair and analysis was performed at the philips authorized service provider which included testing of the alleged device.The results of the analysis were that the device speaker was defective and needed replacement.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 speaker.The issue was resolved by replacing the defective speaker assembly and the product is back in service and was returned to the customer.E1: reporting institution phone#: (b)(6).
Event or Problem Description
It was reported that the device was presented with a speaker malfunction error message and there was no sound coming from the device in standalone mode.The device was in clinical use.There was no report of patient or user harm.

• 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: 50943847
• Report Number: 9610816-2026-102060
• Device Sequence Number: 10451917
• Product Code: MHX
• UDI-Device Identifier: 00884838082588
• UDI-Public: (01)00884838082588
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 09/30/2026

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: IntelliVue X3
• Device Catalogue Number: 867030
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/18/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• 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