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 Prompt/Feedback (2282)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis was performed at the philips authorized repair facility.The device did not complete boot up due to a faulty system board.As a result, testing for the speaker malfunction error could not be performed and the allegation could not be verified.Sound testing was performed with the mt56060 tool.The speaker produced sound.Based on the results of the analysis, a product malfunction was unable to be confirmed.As for precautionary measures, the speaker was replaced and the product was returned to the customer.A review of the service history for this device shows the problem has not been reported again for this device.
Event or Problem Description
Philips received a complaint on a mx40 1.4 ghz smart hopping indicating that there was a speaker malfunction.It is unknown if the speaker produced sound.It is unknown if the device was in clinical use at the time of the event.No adverse event was reported.

• 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: 50853770
• Report Number: 1218950-2026-100652
• Device Sequence Number: 10026383
• Product Code: MHX
• UDI-Device Identifier: 00884838082236
• UDI-Public: (01)00884838082236
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 09/22/2026

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: Health Professional
• Device Model Number: MX40 1.4 GHz Smart Hopping
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2018
• 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