MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX40 WLAN

Model Number	MX40 - WLAN
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/07/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported the telemetry patient was found deceased.The patient was admitted via the emergency department due to chest pain an lower extremity edema.The workup was indicative of mesothelioma with metastasis to the liver.The patient was having intermittent melena stools, for which the nurse called the doctor for orders on more than one occasion.The nurse assessed the patient's vital signs and status at 21:56, 00:09, and at 05:32.Orders were received at 07:08 due to a drop in hemoglobin, indicating two units of prbcs should be given.At approximately 07:15, a nursing aid discovered the patient deceased and a code blue was called.The physician arrived and found the patient was very obviously deceased, with full body pallor and rigor mortis setting in.It was noted at the time of the code that the telemetry pack was not functioning as the battery had been fully discharged.A log review revealed an alarm notification occurred for 'tele service batt' but there was no warning for 'low' or 'empty' battery.The customer requested assistance with the death investigation.
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.E1: reporting institution phone#: unknown.E1: reporter phone#: unknown.

• Brand Name: INTELLIVUE MX40 WLAN
• Common Device Name: INTELLIVUE MX40 WLAN
• 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: 25633354
• Report Number: 1218950-2026-100444
• Device Sequence Number: 9837267
• Product Code: MHX
• UDI-Device Identifier: 00884838082243
• UDI-Public: (01)00884838082243
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2026

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?: 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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2026
• Supplement Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 06/26/2026
• Supplement Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2021
• 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: Death
• Patient Sex: Unknown