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	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: reporter institution phone number: (b)(6).E1: reporter phone number: (b)(6).A philips remote service engineer (rse) interviewed the customer who stated there were no audible alarms.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.
Event or Problem Description
The customer reported the tele speaker indicates a defect.It could not be confirmed if the device produced sound at the time of the event.The device was in use on a patient at the time of the event, there was no adverse event reported.
Additional Manufacturer Narrative
Analysis was performed by a philips remote service engineer (pse) which included interviewing the customer who confirmed the alleged malfunction and recalled it was during preventive maintenance they noticed the tele speaker indicates defective.It could not be confirmed if the device produced sound at the time of the report.The rse planned to approve a quotation for an exchange unit then an onsite after approving quotation.However, the customer did not respond to the quote despite multiple folow-up attempts.As a result, philips cancelled the quotation and the case due to lack of customer engagement.Based on the information available in the case, the cause of the reported problem was confirmed to be a speaker issue.The alleged malfunction was confirmed.If additional information is received, the complaint file will be reopened for further investigation.

• 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: 24614200
• Report Number: 1218950-2026-100139
• Device Sequence Number: 9575553
• Product Code: MHX
• UDI-Device Identifier: 00884838030350
• UDI-Public: (01)00884838030350
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 05/01/2026

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: 02/18/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 05/01/2026
• Date Device Manufactured: 03/11/2021
• 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