MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX800 PATIENT MONITOR; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	INTELLIVUE PATIENT MONITOR MX800
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	02/09/2026
Type of Reportable Event	Serious Injury
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 monitor did not alarm appropriately for hypotension.The patient's noninvasive blood pressure was recorded as 43/37, and a yellow alarm occurred but no red alarm; therefore, the patient's deterioration went unnoticed in the icu.The customer requested assistance in determining why there was no red alarm generated.It was noted the systolic alarm limit was 160 and systolic low was 100.The following was stated by the customer, "this patient was being cared for by a new grad nurse, who actually left the patient to talk to a doctor ¿ not recognizing that this was an emergency and she should have stayed with the patient.Fortunately, there were 2 very senior nurses at the nurse's station who saw the number on the central monitor and went to check on the patient, who was alone and symptomatic in relation to the very low bp.This is a near miss rather than an adverse outcome ¿ however, this scenario could easily re-occur where no one is standing at the monitor observing this, or where its taken automatically and there¿s no nurse in the room, the current tone would not necessarily attract urgent attention and a patient could have an adverse outcome related to this".It was also noted that yellow alarms are noticed but not always immediately resolved or responded to in this care unit.The patient required temporary inotropic medication support with small fluid boluses but there were no adverse effects to the patient noted.The incident was noted to be a near miss as the more senior nurses noted the change in patient condition.There was no evaluation of the device as the device behaved as specified but the lack of red alarms was unexpected for the customer.
Additional Manufacturer Narrative
A philips clinical consultant (cc) reviewed the event and evaluated the device and confirmed that there was no malfunction as the device behaved as intended.The lack of red alarms for nibp was unexpected for the customer, but consistent with the monitor's design and functionality.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLIVUE MX800 PATIENT MONITOR
• 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: 24513454
• Report Number: 9610816-2026-100443
• Device Sequence Number: 18703201
• Product Code: MHX
• UDI-Device Identifier: 00884838020733
• UDI-Public: (01)00884838020733
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: INTELLIVUE PATIENT MONITOR MX800
• Device Catalogue Number: 865240
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown