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	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis was performed by a philips remote clinical support (cs) which included interviewing the customer.During the discussion, the cs explained the possibility of ecg double counting when tall p-waves are present, as they may be misinterpreted as r-waves or t-waves by the system algorithm.The cs explained that a simple way of verify double counting is to compare the heart rate displayed on the monitor with the patient's actual pulse rate.For example, if the patient's pulse rate is approximately 100 bpm while the displayed heart rate is 200 bpm, this strongly suggests double counting.To minimize the likelihood of double counting, the cs advised ensuring the monitor receives the best possible ecg signal.Specifically: the t-wave amplitude should be less than one-third of the r-wave amplitude.The p-wave amplitude should be less than one-fifth of the r-wave amplitude.The rse recommended selecting the ecg lead that provides a tall, monophasic r-wave with a t-wave smaller than the r-wave and a p-wave smaller than the t-wave.If necessary, the primary ecg lead selection should be changed to a more representative lead with these characteristics.If necessary, change the primary lead to better representative lead with these characteristics.Furthermore, the rse advised that if using mx40 at rev.C.01.20 or later, the qrs detection can be adjusted at the central station.(picix rev.C) - instructions for use - 452299165051, page 5-7-15 of the rev.C star_arrhythmiamonitoring dec 2020.The customer reported that the issue has not recurred since these recommendations were provided and stated they will refer clinical staff to the previously shared reference materials should the issue occur again.Based on the information available in the case, the cause of the reported problem was confirmed to be a user issue.The reported problem was not confirmed.If additional information is received, the complaint file will be reopened for further investigation.
Event or Problem Description
The customer reported that the unit was showing a heart rate of 200 while the ecg rate is verified at a lower rate.The device was in use on a patient at the time of the event, there was no adverse event reported.

• 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: 24860492
• Report Number: 1218950-2026-100222
• Device Sequence Number: 13103276
• Product Code: MHX
• UDI-Device Identifier: 00884838030350
• UDI-Public: (01)00884838030350
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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: 03/18/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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