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	05/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple attempts were made to contact the customer regarding the issue to obtain additional details and provide service; however, no response was received; therefore, no analysis was able to be performed.The product malfunction was unable to be confirmed because the customer did not respond to attempts to follow up on the issue.A review of the service history for this device shows the problem has not been reported again for this device.Based on the information available and results of additional analysis, no further action is necessary at this time.If additional information is received, the complaint file will be reopened for further investigation.
Event or Problem Description
Philips received a complaint on an intellivue mmx indicating that intermittently non-invasive blood pressure will not pump.The readings are inaccurate.It is unknown if the device was in use at time of event, and 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: 25505635
• Report Number: 9610816-2026-101141
• Device Sequence Number: 10524766
• Product Code: MHX
• UDI-Device Identifier: 00884838086760
• UDI-Public: (01)00884838086760
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/15/2026

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
• Device Model Number: INTELLIVUE MMX
• Device Catalogue Number: 867036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2020
• 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