MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX400 PATIENT MONITOR; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	INTELLIVUE PATIENT MONITOR MX400
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	03/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: reporting institution phone# (b)(6).A philips remote service engineer (rse) spoke to the customer and found that the problem couldn't be reproduced with another patient nor with another x3 monitor.Eventually it was discovered that both patient cables in use were mechanically damaged.The customer ordered new patient cables to resolve the issue.The customer was provided a replacement patient cables to resolve the issue.It has been concluded 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 mx400 patient monitor indicating there were issues obtaining a 12-lead ecg on the patient.During troubleshooting, the ecg leads and patches were changed numerous times, which lead to skin irritation for the patient.The x3 was then exchanged to resolve the issue.There was damage noted on the ecg cables.Additional information confirmed that no medical intervention was required and that the patient is expected to fully recover.

• Brand Name: INTELLIVUE MX400 PATIENT MONITOR
• 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: 24780013
• Report Number: 9610816-2026-100650
• Device Sequence Number: 6065256
• Product Code: MHX
• UDI-Device Identifier: 00884838038752
• UDI-Public: (01)00884838038752
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K130849
• 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
• Report Date (Section B): 04/03/2026

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 MX400
• Device Catalogue Number: 866060
• 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: 03/12/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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