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	01/06/2026
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: reporting institution phone(b)(6).E1: reporter phone (b)(6).
Event or Problem Description
It was reported that the device did not generate an alarm for desaturation.The device was in use on a patient.There was no report of patient or user harm.
Additional Manufacturer Narrative
Analysis was performed by a philips remote support engineer (rse) which included communication with the customer and historical log file review.The results of the audit log analysis confirms that the relevant spo2 alarms have sounded and were acknowledge by the customer at the bedside device.Spo2 low alarm announced on 06-jan-2026 at 15:36:45, ended at 16:02:22.Spo2 desat alarm announced on 06-jan-2026 at 16:02:15, acknowledged at 16:02:50 at the bedside device.After the log review is was also stated by the rse that a one-minute resolution seems too low for neonatal monitoring where oxygen saturation can rapidly vary, like in the example from 06-jan-2026 at 16:02 with spo2 down to 52 %.The rse recommended to train the end user by a clinical specialist and eventually considering the usage of oxycrg screens with embedded high resolution trend visualization.Alternatively (additionally), using the embedded neonatal event review application with high resolution trend offers more accurate information on events like the reported one.Based on the results of the analysis, the product was confirmed to be operating per specifications and the cause of the reported problem was due to user knowledge.The issue was resolved by providing information to the customer.A review of the service history for this device confirm the problem has not been reported again for this device.

• 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: 24128077
• Report Number: 9610816-2026-100112
• Device Sequence Number: 20185276
• Product Code: MHX
• UDI-Device Identifier: 00884838029088
• UDI-Public: (01)00884838029088
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2018
• 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