MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX450 PATIENT MONITOR; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	INTELLIVUE PATIENT MONITOR MX450
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1; reporter institution phone number: (b)(6).E1: reporter phone number (b)(6).Analysis was performed by onsite field service engineer (fse) which included functional testing and visual inspection.The results of the analysis indicate that the mainboard was faulty.Based on the results of the analysis, it was determined that the product has malfunctioned and the most likely cause of the reported problem was a failure of the main board.The issue was resolved by replacing the main board.The product is back in service.
Event or Problem Description
Philips received a complaint on an intellivue mx450 patient monitor indicating that the speaker was abnormal and no sound was present.The device was not in clinical use at time of event, there was no adverse event reported.

• Brand Name: INTELLIVUE MX450 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: 25599414
• Report Number: 9610816-2026-101224
• Device Sequence Number: 20175715
• Product Code: MHX
• UDI-Device Identifier: 00884838038769
• UDI-Public: (01)00884838038769
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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 MX450
• Device Catalogue Number: 866062
• 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: 05/29/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• 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