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	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis was performed by remote service personnel.The analysis included review of log data, reproduction of the reported alarms using a simulator, and a sound-volume check.The customer reported that an alarm for bradycardia had not sounded during a specified time period.Log analysis showed that alarms were triggered on the reported date, with acknowledgments at the central station and alarm breaks at the monitor.Because the nurse was not able to provide the exact time of the observed event, it could not be determined with certainty whether the logged alarms corresponded to the alarms reported as not heard at the monitor.Simulator testing performed by the customer confirmed the device alarming appropriately, and a sound-volume check was completed.The product malfunction was unable to be confirmed because the exact time of the observed event was not available.Testing completed by the customer confirmed that device was alarming appropriately.The customer has been asked to record the exact date and time if the event occurs again in order to verify more accurately.Reporting institution phone # (b)(6).Reporter phone # (b)(6).
Event or Problem Description
It was reported that the alarms did not sound for a bradycardia event.The device was in use on a patient at the time of the event.There was no adverse event reported.

• 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: 50819029
• Report Number: 9610816-2026-101944
• Device Sequence Number: 21364207
• Product Code: MHX
• UDI-Device Identifier: 00884838083332
• UDI-Public: (01)00884838083332
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/18/2026

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: 08/27/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2021
• 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