MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX40 2.4GHZ; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	MX40 - 2.4
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on a mx40 2.4 ghz smart hopping device indicating that on 7 jan 2026, unit 575473 went offline for 20 seconds.The customer indicated there have been telemetry interruptions in the cardiologist's ward, examination ward and cardiac intensive care unit, where they have lost contact with the central unit (log "equipment offline") so that healthcare staff have not been able to adequately monitor patients.The customer expressed concern over interruptions in a cardiology department where continuous cardiac monitoring is necessary with patients admitted for investigation with cardiac monitoring or patients at risk of life-threatening arrhythmias.The customer further noted that the procedures for these interruptions are resource-intensive and risk other tasks being interrupted, not performed or delayed.The device was in use on a patient at time of event, there was no adverse event reported.
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.

• Brand Name: INTELLIVUE MX40 2.4GHZ
• 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: 25547454
• Report Number: 1218950-2026-100425
• Device Sequence Number: 5571896
• Product Code: MHX
• UDI-Device Identifier: 00884838082243
• UDI-Public: (01)00884838082243
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Report Date (Section B): 06/18/2026

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 - 2.4
• Device Catalogue Number: 865351
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2019
• 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