MAUDE Adverse Event Report: Philips Medizin Systeme Böblingen GmbH IntelliVue Multi-Measurement Module MMX; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Model Number	IntelliVue MMX
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	Bradycardia (1751); Insufficient Information (4580)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Data was collected onsite by a philips field service engineer (fse).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: reporting institution phone #: (b)(6).Section e: reporter phone #: (b)(6).
Event or Problem Description
It was reported that a tachycardia alarm was triggered on the device.Accordingly, an attempt was made to lower the heart rate by administering a beta-blocker (metoprolol).However, the device continued to trigger tachycardia alarms, prompting repeated countermeasures using beta-blockers.As the tachycardia alarm persisted, the user independently measured the heart rate using a non-philips monitor, which revealed that the patient had actually become bradycardic; however, the device did not display a bradycardia alarm following the administration of the medication.As a result, the patient was transferred from the stroke unit to intensive care.No other clinical information or medical intervention was reported; therefore, good faith efforts are being performed.

• Brand Name: IntelliVue Multi-Measurement Module MMX
• 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: 50853769
• Report Number: 9610816-2026-101975
• Device Sequence Number: 15959142
• Product Code: MHX
• UDI-Device Identifier: 00884838086760
• UDI-Public: (01)00884838086760
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181831
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: IntelliVue MMX
• Device Catalogue Number: 867036
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Male