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	04/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: reporter institution phone number: (b)(6).E1: reporter phone number: analysis was performed by philips field service engineer (fse) onsite which included a visual inspection of the unit.The fse checked the device and found that faulty leads were causing the asystole alarm.The fse replaced the leads and cleaned all connections on the device.The unit was tested and it was returned to working specification.Multiple attempts were made to find out if the leads were a philips accessory; however, this information could not be obtained.Based on the information available in the case, the cause of the reported problem was confirmed to be the faulty leads.The alleged malfunction was confirmed.If additional information is received, the complaint file will be reopened for further investigation.
Event or Problem Description
The customer reported that the ecg keeps showing asystole but it's not correct.The customer changed the device, and it was not showing on the other one.Loc: pod e, room 6.812 a.The device was in use on a patient at the time of the event, there was no adverse event reported.
Additional Manufacturer Narrative
Additional information was received indicating measurements were accurate and the unit alarmed due to the faulty lead set triggering the asystole alarm.As per the definition of non-reportable, the inability to analyze the ecg and provide numerics is associated with technical inop alarms "cannot analyze" and "?" to alert the user to the issue.Analysis was performed by philips field service engineer (fse) onsite which included a visual inspection of the unit.The fse checked the device and found that faulty leads were causing the asystole alarm.The fse replaced the leads and cleaned all connections on the device.The unit was tested and it was returned to working specification.Multiple attempts were made to find out if the leads were a philips accessory; however, this information could not be obtained.It was confirmed the measurements were accurate.Based on the information available in the case, the cause of the reported problem was confirmed to be the faulty leads.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: 25171136
• Report Number: 1218950-2026-100315
• Device Sequence Number: 21379984
• Product Code: MHX
• UDI-Device Identifier: 00884838030350
• UDI-Public: (01)00884838030350
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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: 04/13/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2020
• 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