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 Alarm (1019)
Health Effect - Clinical Codes	Arrhythmia (1721); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported the ecg intermittently stops displaying when the patient goes into the bathroom, which could lead to an arrhythmia going undetected; however, there was no evidence an arrhythmia actually occurred.Good faith efforts are being performed to clarify.The device was in use at the time of the event.
Additional Manufacturer Narrative
Additional information was received log files indicated poor signal reception of wlan network.The device did not fail to alarm.As per the definition of non-reportable, the absence or loss of network connectivity would be associated with obvious indicators that data transmission is not occurring.Bedside monitors alarm and display a no central monitoring inop message; mx40s enter monitor mode, alarm locally and display a no central monit.Message; trx4841a/trx4851a transceivers generate a beep sound to indicate that there is no central monitoring.The user is instructed to implement alternate means of monitoring as warranted.Analysis was performed by philips remote service engineer (rse) who interviewed the customer.It was determined the cause of the reported display issue was poor signal reception in the wlan network, though it was confirmed all access points at the patient location were functioning.The it department was responsible for the network, so the resolution will be done within the hospital.The log files were reviewed, confirming the device did not fail to alarm for the signal issues, so the device was providing notification as designed.There was no actual known arrythmia reported during the time of the signal loss.There has not been any new incidents with this particular unit.Based on the information available in the case, the cause of the reported problem was confirmed to be poor signal reception in the wlan network.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: 25449102
• Report Number: 1218950-2026-100390
• Device Sequence Number: 12203528
• Product Code: MHX
• UDI-Device Identifier: 00884838030350
• UDI-Public: (01)00884838030350
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 07/02/2026
• Date Device Manufactured: 12/05/2019
• 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