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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke with the customer biomed.The biomed stated that the invasive blood pressure is out of range and he is unable to calibrate the device.The biomed stated that when attempting to calibrate the mmx module's invasive pressure calibration, the setup button and then select "cal press" on the screen to start the calibration process is unavailable.The biomed also stated that the option for calibration was under the mmx with software version n.0, but not under the m.04.The rse confirmed with biomed that after applying the test patient simulator with a reusable ibp transducer (reusable transducer are used for test and verification of patient monitoring equipment and not for patient use) for the mmx module, the "cal press" option was not under the menu when selecting the setup menu in order to calibrate the mercury to 200 mmhg.The rse had the biomed perform a cold restart on the module but that did not resolve the issue.The rse requested assistance form a philips clinical support specialist (css) with the issue.The css advised the biomed that the calibration needs to be enabled in configuration prior to entering "cal factor" and "cal pressures".The css stated that in the user's guide (intellivue_patient_monitor_rel._n.0_configuration_guide_4535_647_90761_(eng)) it states: if you want users to be able to perform a mercury calibration while in monitoring mode, set mercury cal to yes.The biomed confirmed that once enabled, he was able to see the "cal pressure" and "cal factor" fields in the ibp menu.Based on the results of the analysis, the product was confirmed to be operating per specifications, and the cause of the reported problem was a configuration issue.The biomed was provided the instructions for enabling and performing calibration.
Event or Problem Description
It was reported that the invasive blood pressure is out of range.The device was not in use on a patient at the time of the event.There was no adverse event reported.

• 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 ; 70314632031
• MDR Report Key: 25096479
• Report Number: 9610816-2026-100885
• Device Sequence Number: 9990800
• Product Code: MHX
• UDI-Device Identifier: 00884838086760
• UDI-Public: (01)00884838086760
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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: Other
• Device Model Number: INTELLIVUE MMX
• Device Catalogue Number: 867036
• 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: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2019
• 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