MAUDE Adverse Event Report: Philips Medizin Systeme Böblingen GmbH IntelliVue MX550 Patient Monitor; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Model Number	IntelliVue Patient Monitor MX550
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the intellivue mx550 patient monitor indicating that a camera failure was reported and that the device displayed blood pressure readings that were higher than expected.
Additional Manufacturer Narrative
The investigation indicated that the customer contacted philips and was provided with onsite support through a field service engineer (fse).Based on the results of the onsite inspection, the reported blood pressure issue could not be reproduced.The fse tested the intellivue mx550 patient monitor with the intellivue x3 measurement server, and all measurements were taken correctly.The non-invasive blood pressure (nbp) leakage, accuracy, linearity, and calibration tests passed.It was determined that the blood pressure reference method had been configured as invasive.To address the customer¿s concern, the fse changed the reference method from invasive to auscultatory.The verification tests passed after the setting was changed.

• Brand Name: IntelliVue MX550 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 ; +49(703)14632031
• MDR Report Key: 50771946
• Report Number: 9610816-2026-101897
• Device Sequence Number: 9717088
• Product Code: MHX
• UDI-Device Identifier: 00884838038783
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K131872
• 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): 09/15/2026

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 MX550
• Device Catalogue Number: 866066
• 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: 08/21/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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