MAUDE Adverse Event Report: Philips Medizin Systeme Böblingen GmbH IntelliVue MX450 Patient Monitor; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Model Number	IntelliVue Patient Monitor MX450
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was admitted to the department for worsening chest tightness for one day after repeated chest tightness for over ten years.At 21:00 on (b)(6) 2026, the patient's blood pressure was measured to be 78/48 mmhg.Then 200mg of dopamine hydrochloride injection was administered intravenously at 6 ml/h.A follow-up blood pressure measurement showed an ecg monitor reading of 66/58 mmhg, while the medical electronic blood pressure monitor measured 88/50 mmhg, which was indicated to contain errors.Subsequent blood pressure readings from the ecg monitor were slightly low, while the medical electronic blood pressure monitor's was higher than those with errors.The medical staff subsequently used the medical electronic blood pressure monitor for treatment and care.There was no harm to the patient; however, it was indicated that there was a significant deviation in values, which affected the diagnosis.No other clinical information or medical intervention was provided; therefore, good faith efforts are being performed.
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.Section e: reporter phone #: (b)(6).

• Brand Name: IntelliVue MX450 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 ; +49(703)14632031
• MDR Report Key: 50497159
• Report Number: 9610816-2026-101750
• Device Sequence Number: 13124333
• Product Code: MHX
• UDI-Device Identifier: 00884838038769
• UDI-Public: (01)00884838038769
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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 MX450
• Device Catalogue Number: 866062
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 08/28/2026
• Date Device Manufactured: 08/29/2018
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown