MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX750 PATIENT MONITOR

Model Number	866471
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.E1: reporter: (b)(6).
Event or Problem Description
It was reported the monitor does not give a 3-star alarm.It could not be read from the monitor.The device was in use on patient at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
Box d : based upon updated information, product name changed from intellivue fmx-4 (866468) to 866471 intellivue mx750 patient monitor a philips representative interviewed the customer, and it was reported the device did not give a red alarm for low invasively measured blood pressure values.The philips representative indicated the configuration of the monitors needed to be adjusted.Based on the information provided in the case, the cause of the reported problem was a configuration issue.The device's alarm limit values were not defined/configured for invasive blood pressure (ibp) red alarms.No further investigation or action is warranted at this time.Based on updated information, this record has become non-reportable.The product ships with factory default configuration which has been reviewed by product and clinical experts and determined to be safe for use.During interaction with the device, the customer may notice settings that may not be as expected, at which time the user can customize the settings themselves until user defaults that are customer-specific can be configured in order to qualify continued use of the monitoring equipment.Product labeling indicates that the most reliable method of patient monitoring combines close personal surveillance with correct operation of the monitoring equipment.

• Brand Name: INTELLIVUE MX750 PATIENT MONITOR
• Common Device Name: INTELLIVUE MX750 PATIENT MONITOR
• 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: 21032266
• Report Number: 9610816-2024-001026
• Device Sequence Number: 9180417
• Product Code: MHX
• UDI-Device Identifier: 00884838086982
• UDI-Public: (01)00884838086982
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 02/25/2025

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: 866471
• Device Catalogue Number: 866471
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 12/29/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2020
• 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