MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE PATIENT MONITOR MX700; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

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	04/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that monitor did not generate an alarm for a high heart rate.The device was in use on a patient at the time of the event.There was no adverse event reported.
Additional Manufacturer Narrative
Philips remote clinical support (rcs) contacted the customer biomed who stated the monitor showed the patient's electrocardiogram (ecg) heart rate value = 125 beats per minute (bpm) but the monitor did not generate a heart rate (hr) yellow or red visual or audible alarm.The rcs advised the biomed to check the monitors' ecg default alarm settings.The biomed confirmed the following settings: monitors heart rate (default) limits = low 45- high 150 bpm - extreme alarms +/- 20.The rcs then advised the biomed to check the patient's ecg- hr tabular trends (under pic ix trend review).The biomed provided the following result: trend review show the heart rate value =125 bpm at on (b)(6) 2026 4:27am - patient's ecg strip shows heart rate value =125 bpm.The rcs reviewed the ecg/arrhythmia heart rate alarm structure and explained to the biomed that the patient's heart rate was within normal limits based on the current configuration.As a result, the monitor would not have activated a yellow (*) or red (**) alarm.Based on the results of the analysis, the product was confirmed to be operating per specifications, and the cause of the reported problem was the customer not understanding alarm configuration.

• Brand Name: INTELLIVUE PATIENT MONITOR MX700
• 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 ; 70314632031
• MDR Report Key: 25148493
• Report Number: 9610816-2026-100914
• Device Sequence Number: 10745129
• Product Code: MHX
• UDI-Device Identifier: 00884838029088
• UDI-Public: (01)00884838029088
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: 04/16/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2016
• 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