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 Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Diagnostic/functional testing was performed at the philips authorized repair facility.Results of functional testing indicate that the speaker doesn't work in the unit.It states there is a speaker malfunction on the pic station and the speaker doesn't work with the fixture.The speaker was replaced.The device was operational after repairs were completed and the device was returned to the customer.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
Event or Problem Description
Philips received a complaint on the mx40 1.4 ghz smart hopping device indicating that, during evaluation at bench repair, the device had no sound.The device was not in use on a patient at the time of the event, there was no patient involvement.

• 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 ; 6172455900
• MDR Report Key: 23035625
• Report Number: 1218950-2025-000524
• Device Sequence Number: 9514764
• Product Code: MHX
• UDI-Device Identifier: 00884838026568
• UDI-Public: (01)00884838026568
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/12/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2019
• 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