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
During evaluation at bench repair, it was identified that the device had no speaker sound at start up test.The device was not in use on a patient at the time of the event, there was no patient involvement.
Additional Manufacturer Narrative
Analysis was performed by bench repair personnel to evaluate the reported issue.During testing, the no-speaker-sound condition at startup was confirmed.The speaker was connected to the mt56060 diagnostic tool; however, no audio output was produced.Additional testing was conducted using an ohmmeter to measure the speaker directly.The measurement indicated an open circuit condition, confirming that the speaker had failed and was incapable of producing sound.Based on the results of the analysis, it was determined that the product malfunctioned due to a faulty speaker.The most likely root cause of the reported problem was an internal speaker failure resulting in an open circuit condition.The issue was resolved by replacing the speaker and the product 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: 50895918
• Report Number: 1218950-2026-100663
• Device Sequence Number: 17599540
• Product Code: MHX
• UDI-Device Identifier: 00884838082236
• UDI-Public: (01)00884838082236
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 08/31/2026
• 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: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2017
• 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