MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE PATIENT MONITOR MX700

Model Number	INTELLIVUE PATIENT MONITOR MX700
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
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.
Event or Problem Description
It was reported the customer missed a yellow non-invasive blood pressure alarm.There was no report of actual harm associated with this complaint.The customer requested assistance determining why the yellow nibp alarm was not displayed.
Additional Manufacturer Narrative
A philips' on-site field service engineer (fse) was able to observe the situation; the yellow alarm was not triggered but can be found in the alarm memory and in the clinical audit trail.Further investigation found that the mx 700 monitors in the rooms are all configured to 0 volume.In addition, the yellow alarm was configured not to evaluate (that can be used to generate audible alarms even if the user has turned alarm volume to 0).The default nbp alarms are set to alarm only on the systolic measurement and for the systolic measurement the default values are set to 180 mmhg as high alarm and 90mmhg as low alarm.A review of the central station logs indicated the device was functioning as expected.A software update was completed, and the alarm functionality was confirmed, and no further events were reported.The device(s) was returned to full use functional after the software update.The device(s) was confirmed ready for clinical use.Based on the information provided, the investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.The customer will be notified of these findings.

• Brand Name: INTELLIVUE PATIENT MONITOR MX700
• Common Device Name: INTELLIVUE PATIENT MONITOR MX700
• 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: 23758479
• Report Number: 9610816-2025-001190
• Device Sequence Number: 13294805
• Product Code: MHX
• UDI-Device Identifier: 00884838029088
• UDI-Public: (01)00884838029088
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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 MX700
• Device Catalogue Number: 865241
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2017
• 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