MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE PATIENT MONITOR MX750; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	INTELLIVUE PATIENT MONITOR MX750
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips clinical support specialist spoke with the biomed regarding reports of frequent alarms and questionable ecg values while monitoring patients in the picu.It was determined that the ecg voltage was not significant enough to consistently meet the threshold of 150uv due to patient physiology, resulting in some ecg beats not being detected by the monitor.There was no patient impact, and monitoring was not interrupted.The biomed was advised to select 'annotate arrhythmia' to visualize beat classifications and confirmed that some ecg complexes did not have annotations, concurring that the ecg signal may be weak.The qrs detection threshold was verified to be set at its lowest (150uv).Further recommendations included improving ecg detection by moving leads closer to the heart while maintaining the same axis, ensuring good skin preparation (using soap and water, drying the skin, and using fresh or wet-gel electrodes), and ensuring proper lead placement.A summary of steps was emailed to the biomed, and follow-up was requested.On 5/12, the biomed reported that caregivers were counseled on troubleshooting steps and no further questions were received.The system meets specification for the performed service and was returned to use.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.
Event or Problem Description
Philips received a complaint on the intellivue mx750 patient monitor indicating that the heart rate on the ekg is varying by a large degree compared to the spo2 heart rate.The device was in use on a patient at time of event, there was no adverse event reported.

• Brand Name: INTELLIVUE PATIENT MONITOR MX750
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 25148993
• Report Number: 9610816-2026-100917
• Device Sequence Number: 16138673
• Product Code: MHX
• UDI-Device Identifier: 00884838083332
• UDI-Public: (01)00884838083332
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K210906
• 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): 05/12/2026

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: Health Professional
• Device Model Number: INTELLIVUE PATIENT MONITOR MX750
• Device Catalogue Number: 866471
• 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: 05/08/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• 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