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
Additional Manufacturer Narrative
E1; reporter institution phone number: (b)(6).E1: reporter phone number: a follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that the device was giving the error message speaker error and no sound was emitted.It is unknown if the device was in clinical use at time of event, no adverse event was reported.
Additional Manufacturer Narrative
A quote was provided to customer to provide additional repair and device.Multiple attempts were made to obtain the device context of use, evaluation, repair, and operational status with no response from the customer.The product malfunction was unable to be confirmed because the customer did not respond to the quote.Multiple attempts were made to obtain the device context of use, evaluation, repair, and operational status with no response from the customer.No further information was provided.A supplemental report will be submitted if new information is obtained.A review of the service history for this device shows the problem has not been reported again for this device.

• 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 ; 6172455900
• MDR Report Key: 24938826
• Report Number: 1218950-2026-100239
• Device Sequence Number: 5357057
• Product Code: MHX
• UDI-Device Identifier: 00884838030350
• UDI-Public: (01)00884838030350
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/03/2026

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 - WLAN
• Device Catalogue Number: 865352
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 05/09/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 06/03/2026
• Date Device Manufactured: 07/14/2017
• 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