MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX40 2.4GHZ

Model Number	MX40 - 2.4
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device reset some red alarms without user interaction.The device was in clinical use.There was no report of patient or user harm.
Additional Manufacturer Narrative
Analysis was performed by onsite and remote service personnel which included talking to the customer, testing of the device and log history review.The results of the analysis were that the field service engineer (fse) who was dispatched onsite confirmed he has verified that the red alerts are appearing correctly and no anomalies are detected.The alarms are displayed without automatically turning off.The log review has also been performed, and no issues are found.However, the telemetry software has been reloaded and the department has been shown how to perform correct arrhythmia reacquisition.The customer has agreed the system is working to its specification and ready to use.Based on the results of the analysis, the product was confirmed to be operating per specifications and the cause of the reported problem was that a new approach has been attempted by the customer for remote resolution.In all likelihood, the red alerts, which were initially silenced regularly, are periodically re-sent with an alarm condition that does not resolve.This alert also silences itself until the alarm condition resolves.The issue was resolved by showing the department how to perform correct arrhythmia reacquisition.A review of the service history for this device shows the problem has not been reported again for this device.E1: reporting institution phone #: (b)(6).E1: reporter phone #: (b)(6).

• Brand Name: INTELLIVUE MX40 2.4GHZ
• Common Device Name: INTELLIVUE MX40 2.4GHZ
• 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: 24940478
• Report Number: 1218950-2026-100241
• Device Sequence Number: 8946405
• Product Code: MHX
• UDI-Device Identifier: 00884838082243
• UDI-Public: (01)00884838082243
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K113125
• 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): 04/21/2026

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: MX40 - 2.4
• Device Catalogue Number: 865351
• 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: 04/09/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2019
• 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