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

Model Number	MX40 - WLAN
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction

• Brand Name: IntelliVue MX40 WLAN
• 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: 50220402
• Report Number: 1218950-2026-100553
• Device Sequence Number: 10315941
• Product Code: MHX
• UDI-Device Identifier: 00884838030350
• UDI-Public: (01)00884838030350
• 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): 08/12/2026

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 - WLAN
• Device Catalogue Number: 865352
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/23/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2021
• 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