MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE PATIENT MONITOR MX700; INTELLIVUE MX700 PATIENT MONITOR

Model Number	INTELLIVUE PATIENT MONITOR MX700
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.Reporter institution phone number: (b)(6).Reporter phone number: (b)(6).
Event or Problem Description
It was reported the patient developed a burn at the electrode site while being monitored.An unknown medical intervention occurred, and the burn was expected to heal completely with no permanent damage.The burn did not occur during an mri.No other clinical information was provided; therefore, good faith efforts are being performed.
Additional Manufacturer Narrative
The following communications were performed: multiple meetings were arranged between philips and the philips distributor to establish the root cause of the event.Philips provided information to the distributor on the use of the ecg cables and the equipotential grounding of the devices, as stated in the instructions for use (ifu).Philips recommended the distributor an onsite visit by trained philips staff to assess the situation and evaluate the devices.The customer stated they cannot and will not provide more information and declined the onsite visit.It was confirmed that they have indicated that they have ruled out our monitors as the cause of the injury.Multiple good faith efforts attempts have been conducted to gather more information but have been unsuccessful.Made several attempts to obtain product and serial for the measurement server used with intellivue mx700.Based on the information available and the testing conducted, the cause of the reported problem is unknown.The reported problem was not confirmed.We are unable to confirm the final disposition of the device, because the customer did not respond to requests for additional information.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 PATIENT MONITOR MX700
• Common Device Name: INTELLIVUE MX700 PATIENT MONITOR
• 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: 22326299
• Report Number: 9610816-2025-000521
• Device Sequence Number: 8812069
• Product Code: MHX
• UDI-Device Identifier: 00884838029088
• UDI-Public: (01)00884838029088
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K150310
• 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): 11/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: INTELLIVUE PATIENT MONITOR MX700
• Device Catalogue Number: 865241
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown