MAUDE Adverse Event Report: Philips Medical Systems IntelliVue MX40 2.4GHz; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Model Number	MX40 - 2.4
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that that the alarm is not triggered when the heart rate reaches the configured threshold.It was unknown if the device was in use on a patient at the time of the event.There was no adverse event reported.
Additional Manufacturer Narrative
No analysis was performed onsite or remotely.Field service personnel were required to check the issue, so the customer was provided a quote for service.The customer confirmed that onsite support was not required and the quote was declined.No additional information was provided by the customer.The product malfunction was unable to be confirmed because the customer declined on site support.It is unknown how the issue was resolved.Based on the information available and results of additional analysis, no further action is necessary at this time.If additional information is received, the complaint file will be reopened for further investigation.(b)(6).

• Brand Name: IntelliVue MX40 2.4GHz
• 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: 50754157
• Report Number: 1218950-2026-100627
• Device Sequence Number: 13178764
• Product Code: MHX
• UDI-Device Identifier: 00884838082243
• UDI-Public: (01)00884838082243
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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 - 2.4
• Device Catalogue Number: 865351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/14/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2019
• 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