MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX40 WLAN; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	MX40 - WLAN
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were no alarms.The device was reported to be in use on a patient.No adverse event to the patient or user was reported.
Additional Manufacturer Narrative
E1 reporter phone #: (b)(6).E1 reporting institution phone #: philips field service personnel visited the site to assess the issue.During the investigation, the user indicated that certain waveforms were expected to generate alarms; however, review of the central station data showed no alarms occurring at the specific times identified by the user.Clinical logs were collected and forwarded to the clinical team for further analysis.Functional testing of the device was performed using a simulator, and the unit operated as intended with no faults identified.The device was confirmed to be in proper working condition and was returned to service.Additionally, onsite clinical support engaged with the users to review system functionality and provided training to ensure proper understanding of alarm behavior and system operation.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.
Additional Manufacturer Narrative
Additional information was received clarifying the customer's issue.Specifically, the users indicated that they expected certain waveforms were expected to trigger alarms; however, no alarms were observed during the reported events.In addition, it was indicated that waveforms appeared fuzzy.Analysis was performed by a philips field service personnel, who visited the customer site to assess the reported issue.During the investigation, the user identified specific time periods where alarms were expected to occur.Review of the central station data demonstrated that no alarm conditions were present at the times identified by the user.Clinical logs were collected and forwarded to the philips clinical team for further evaluation and analysis.Functional testing of the device was performed using a simulator, and the unit operated as intended with no faults identified.The device was confirmed to be functioning within specifications and was subsequently returned to service.In addition, onsite clinical support met with the users to review system functionality and provided training regarding alarm behavior, waveform interpretation, and overall system operation to ensure proper understanding and use of the device.Based on the investigation results, the product was confirmed to be operating per specifications, and the reported issue was attributed to the need for additional customer training.A review of the service history for this device determined that this issue has not been reported again for this device.

• Brand Name: INTELLIVUE MX40 WLAN
• 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: 24898180
• Report Number: 1218950-2026-100230
• Device Sequence Number: 9845018
• Product Code: MHX
• UDI-Device Identifier: 00884838030350
• UDI-Public: (01)00884838030350
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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,Followup
• Report Date (Section B): 05/12/2026

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 - WLAN
• Device Catalogue Number: 865352
• 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: 03/19/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2022
• 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