MAUDE Adverse Event Report: Philips Medical Systems IntelliVue MX40 1.4GHz; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	MX40 1.4 GHz Smart Hopping
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint regarding an intellivue mx40 1.4 ghz smart-hopping telemetry device indicating that, during preventive maintenance testing, the displayed spo2 values were observed to fluctuate significantly and inconsistently, with readings varying from the 60% range to the low 90% range.No patient involvement was reported at the time the issue was identified.
Additional Manufacturer Narrative
The device evaluation identified intermittent poor link quality between the mx40 telemetry device and the patient information center (pic), resulting in lagging of readings transmitted to the pic.Investigation found fuzzy debris on the kapton tape installed on the radio board and slight damage to the antenna.Both contamination on radio-frequency components and antenna damage can adversely affect wireless communication performance and signal quality.Degraded wireless communication may result in delayed, intermittent, or inconsistent transmission of physiological data to the central monitoring system, which could manifest as fluctuating or unstable displayed spo2 readings at the pic.Based on the product analysis findings, the intermittent poor rf link quality, potentially caused by the debris present on the radio board area and the slight antenna damage, could have contributed to the customer's observation of spo2 values intermittently fluctuating between the 60s and low 90s due to delays or inconsistencies in the transmission of patient data to the pic.However, the product analysis did not establish that the device itself was generating inaccurate spo2 measurements; rather, the findings suggest a communication-related issue affecting the display of readings at the central station.The radio board and antenna were replaced and the device was returned to the customer.

• Brand Name: IntelliVue MX40 1.4GHz
• 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: 50487380
• Report Number: 1218950-2026-100589
• Device Sequence Number: 18670019
• Product Code: MHX
• UDI-Device Identifier: 00884838082236
• UDI-Public: (01)00884838082236
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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 1.4 GHz Smart Hopping
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2018
• 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