MAUDE Adverse Event Report: Philips Medizin Systeme Böblingen GmbH IntelliVue Patient Monitor MX750; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Model Number	IntelliVue Patient Monitor MX750
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on an intellivue mx750 patient monitor indicating that the device does not make sound alarm when connected to evo ventilator.The device was in clinical use on a patient at the time of the event.No adverse event was reported.
Additional Manufacturer Narrative
E1 reporting institution phone#: (b)(6).E1 reporter phone#: (b)(6).Analysis was performed remote service personnel which included discussions with the customer biomed and indicated the issue is replicated.The biomed has checked connectors and verified the volume for the monitor had a volume of 7 out of 10.The biomed agreed to continue fault finding exchanging various parts to determine if a failing part could be located.No further information was received from the biomed.Based on the results of the analysis, it was determined that the product has malfunctioned and the cause of the malfunction is unknown as the customer did not provide further information regarding the issue.The final disposition of the device is unknown.If additional information is received, the complaint file will be reopened for further investigation.

• Brand Name: IntelliVue Patient Monitor MX750
• 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: 50950956
• Report Number: 9610816-2026-102066
• Device Sequence Number: 13349414
• Product Code: MHX
• UDI-Device Identifier: 00884838083332
• UDI-Public: (01)00884838083332
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K210906
• 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): 09/30/2026

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 MX750
• Device Catalogue Number: 866471
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2025
• 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