MAUDE Adverse Event Report: Philips Medical Systems IntelliVue MX40 1.4GHz; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	MX40 1.4 GHz Smart Hopping
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint involving an intellivue mx40 patient monitor.The biomedical technician reported that nursing staff indicated the unit would not power on.However, during subsequent testing by the biomedical technician, the device powered on and displayed a continuous speaker malfunction condition.The mx40 was not in use on a patient at the time of the event and no patient involvement was reported.The device was reportedly not producing audible sound and was sent to the bench for further evaluation and repair.No patient or user injury occurred as a result of this event.
Additional Manufacturer Narrative
Analysis was performed by bench repair personnel which included efforts to reproduce the reported issue.During evaluation, the reported issue was replicated, and the device speaker did not produce audible sound when installed in the mx40.The speaker was subsequently tested using the mt56060 test tool and was found to function properly, producing audible sound as expected.Further troubleshooting determined that the system board was the source of the problem.Based on the results of the analysis, it was determined that the product malfunctioned and that the most likely cause of the reported problem was a failure of the system board, which prevented proper speaker operation within the device.The issue was resolved by replacing the system board, and the product was restored to proper operation and will be returned to the customer.

• Brand Name: IntelliVue MX40 1.4GHz
• 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 ; +1(617)245-5900
• MDR Report Key: 50886006
• Report Number: 1218950-2026-100661
• Device Sequence Number: 10704871
• Product Code: MHX
• UDI-Device Identifier: 00884838082236
• UDI-Public: (01)00884838082236
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/24/2026

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: Other
• Device Model Number: MX40 1.4 GHz Smart Hopping
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/15/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2019
• 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