MAUDE Adverse Event Report: Philips Medizin Systeme Böblingen GmbH IntelliVue MX800 patient monitor; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	IntelliVue Patient Monitor MX800
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that no alarm triggered.The device was in use on a patient at the time of event, there was no adverse event reported.
Additional Manufacturer Narrative
E1: (b)(6).A philips remote technical support specialist (tss) interviewed the customer who reported no alarm was perceived despite low invasive arterial blood pressure (art) values on (b)(6) 2026 between 04:00¿05:00.The customer requested verification of alarm functionality, alarm configuration, and system behavior.The reported issue could not be reproduced under investigation conditions as the monitor had been removed from clinical service for investigation.Alarm annunciations were recorded by the system.No evidence was found that art alarms were disabled.The tss reviewed the available audit data, alarm generation could be verified and a device hardware or software malfunction could not be confirmed.Multiple ¿pause all alarms¿ events, alarm acknowledgements, and transitions into pause/standby mode were identified within the reviewed period.Art alarm limits were modified during the investigation period, including changes of the art lower limit (65, 60, 50, 55 mmhg).Frequent art signal quality related events (art no pulse, art signal disturbance, art range?) were also documented.These findings indicate that alarm configuration changes, alarm pause functions, workflow-related actions and/or intermittent invasive pressure signal quality issues may have contributed to the reported perception that no alarm occurred.A philips field service engineer (fse) went onsite to further evaluate the unit.The fse could not confirm the alleged malfunction as performance verification and testing produced no malfunction.The alarms were set according to the configuration.The fse stated the analysis by tss - alarm behavior corresponds to configuration.Based on the information available in the case and the logs provided by the customer, the unit operated as designed.There was no product malfunction.If additional information is received, the complaint file will be reopened for further investigation.

• Brand Name: IntelliVue MX800 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: 50681594
• Report Number: 9610816-2026-101840
• Device Sequence Number: 20153293
• Product Code: MHX
• UDI-Device Identifier: 00884838020733
• UDI-Public: (01)00884838020733
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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 MX800
• Device Catalogue Number: 865240
• 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: 08/10/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• 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