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	Defective Alarm (1014)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Tachycardia (2095)
Date of Event	07/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the mx40 telemetry device did not alarm at the bedside and the central station did not generate an alarm when the icu patient coded.During the hospital it wireless system upgrade from 5:30-6:30am for which staff had been notified, the patient coded while on telemetry at 5:58am.The monitoring unit staff indicated all surveillance and overview display patient sectors turned blue with no alarms generated.The patient's family indicated the telemetry device did not generate local audible alarms at the bedside.Biomed reviewed the clinical audit log, revealing the mx40 was offline from 5:48-6:21, as evidenced by the technical alarm of no data mon.It was also noted a v-tach alarm was generated at 05:45 at the bedside.The patient had gone to the bathroom and when they came back, they coded.The family had noticed the patient was 'not looking good' and notified staff.The patient was life flighted to another hospital for advanced care.
Additional Manufacturer Narrative
Philips remote clinical support assisted the onsite biomed who reviewed the clinical audit trail and it appeared that the mx40 monitor equipment offline (no data mon) from timeframe on (b)(6) 2026 5:48 am to 6:21 am.An onsite work order was created to retrieve the following: clinical audit trail, pic ix surveillance clinical (config ) settings, device logs and confirm the mx40 monitor and pic ix application is performing as expected.Analysis was performed by onsite service personnel which included gathering of the clinical audit trail logs, review of the mx40 device report, review of telemetry strips provided by the customer, review of surveillance and overview station clinical settings, verification of mx40 functionality, and connectivity testing with the central station with no issues identified.The mx40 successfully passed all functionality testing and was confirmed to be operating as designed at the time of the onsite evaluation.Based on the information provided, it appears that adequate monitoring processes may not have been in place during the planned wireless network downtime, which contributed to the reported event.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 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 ; +1(617)245-5900
• MDR Report Key: 50477800
• Report Number: 1218950-2026-100586
• Device Sequence Number: 10203951
• Product Code: MHX
• UDI-Device Identifier: 00884838030350
• UDI-Public: (01)00884838030350
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 08/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown