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 Code	Insufficient Information (4580)
Date of Event	08/27/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that a device was in use while a patient died; however, there was no connection and no data from the device.It was indicated that testing of the device showed no issues, and it was noted that 3rd party batteries were used and not securely held in the battery compartment.Resuscitation efforts were initiated but subsequently discontinued in accordance with the patient's previously expressed wishes that no resuscitation be performed.No additional clinical information was provided.
Additional Manufacturer Narrative
E1 reporting institution phone #: (b)(6).It was reported that third-party batteries (akku med) were being used with the device and did not fit securely within the battery compartment.Additionally, broken battery clips were identified.Functional testing performed by the customer using a patient simulator did not identify any issues with the mx40 monitor.A philips field service engineer (fse) visited the customer site to collect device logs and supporting information related to the reported event.Analysis of the device logs and clinical audit records determined that the mx40 was not connected to the pic ix system on 27-aug-2026 between approximately 06:00 and 16:39.No retrospective patient data were available for this time period.The fse also performed functional testing of the monitor, and no anomalies were identified.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: 50950279
• Report Number: 1218950-2026-100680
• Device Sequence Number: 13149682
• Product Code: MHX
• UDI-Device Identifier: 00884838030350
• UDI-Public: (01)00884838030350
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/30/2026

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: 09/01/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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: Female
• Patient Weight: 176 LB