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	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This report is based on information provided by a philips remote service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the mx40 2.4 ghz smart hopping indicating that when a patient had a 27-beat run of supraventricular tachycardia (svt), the monitor did not alarm, so the arrythmia was not noticed right away.The default configuration had svt arrythmia alarms turned off; however, it was unclear if the svt alarm was turned off or on at the time of this event.The default configuration for an svt alarm is a heartrate of 180 and a run of 10.When the patient had the arrythmia event, the patient's heartrate was in the 130's.There was no report of actual harm.
Additional Manufacturer Narrative
A philips clinical transformation manager spoke to the customer, who confirmed that they lowered the hr parameter for the svt alarm to resolve the issue.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: 50884065
• Report Number: 1218950-2026-100660
• Device Sequence Number: 9939350
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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