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	04/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips remote application specialist (ras) spoke to the biomed and assist nurse manager who stated that they are expecting red pressure alarms, but they are being called as yellow alarms.The arterial blood pressure (abp) alarms are not functioning properly.The ras checked the bedside configuration which indicated that extreme alarms for arterial (art), arterial blood pressure (abp) and (pulmonary artery pressure) pap are disabled by default, alarm latching is set to red only for visual and audible.The ras explained the difference between red disconnect inops and red patient alarms.They would see red inops for invasive pressures but not for physiologic red alarms.The ras was unable to remote into the customer network to review the audit logs.The customer biomed reviewed the audit logs and provided the following information, the biomed also sent the audit logs to the ras for review.The log analysis identified yellow low abp alarm were noted in logs on 5 devices at time staff reported they did not hear the alarm.The biomed checked the pic's audible alarm and was able to hear red/yellow alarms.The biomed also checked the alarms on the device by changing the art high limit from 160 to 120 to trigger the alarm, the device alarmed as expected.All alarms noted for art, and overrange inop are confirmed to be functioning as expected.Based on the results of the analysis, the product was confirmed to be operating per specifications, and the cause of the reported problem was not able to be identified.The nurse manage and biomed were satisfied with the test performed indicating the alarms were working as expected.
Event or Problem Description
It was reported that that the arterial blood pressure (abp) alarms are not functioning properly.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 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: 25111884
• Report Number: 9610816-2026-100889
• Device Sequence Number: 13359822
• Product Code: MHX
• UDI-Device Identifier: 00884838029088
• UDI-Public: (01)00884838029088
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 05/07/2026

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: 04/09/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2020
• 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