MAUDE Adverse Event Report: Philips Medical Systems IntelliVue MX40 1.4GHz

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	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device was presented with a speaker malfunction error message and it is unknown if there was still sound.The device was not in clinical use.There was no report of patient or user harm.
Additional Manufacturer Narrative
The device was returned and analysis was performed at the philips authorized repair facility which included functional testing.Results of functional testing indicate that the speaker produced sound and the device did not display a speaker malfunction error message.Based on the results of the analysis, the product was confirmed to be operating per specifications and the product malfunction was unable to be confirmed and the cause remains unknown.Although the speaker was confirmed to be functioning per specification during testing it was indicated that there was no sound at the time of the event, the speaker has been replaced per current process.The device was operational after repairs were completed.

• Brand Name: IntelliVue MX40 1.4GHz
• Common Device Name: IntelliVue MX40 1.4GHz
• 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: 50946354
• Report Number: 1218950-2026-100678
• Device Sequence Number: 13373544
• Product Code: DSI
• UDI-Device Identifier: 00884838082236
• UDI-Public: (01)00884838082236
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 09/30/2026

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: 09/16/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2026
• 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