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	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported nibp is not deflating.The device was in use at the time of the event, there was no adverse event reported.
Additional Manufacturer Narrative
A philips remote technical support engineer (tse) interviewed the customer and recommended nbp calibration, accuracy verification, leak testing, and advised replacement of the nbp pump assembly if testing failed or the issue persisted.The customer¿s biomed representative agreed to perform the recommended testing and obtain a replacement nbp pump assembly if necessary.Part number information was provided.Based on the remote assessment, the nbp pump assembly may require calibration or replacement.The customer assumed responsibility for further servicing of the device.No additional information is expected, as philips remote support for this event has concluded.The product malfunction was unable to be confirmed because the customer resolved the issue on their own.A review of the service history for this device shows the problem has not been reported again for this device.If additional information is received, the complaint file will be reopened for further investigation.

• 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: 50816127
• Report Number: 9610816-2026-101941
• Device Sequence Number: 10127500
• Product Code: MHX
• UDI-Device Identifier: 00884838086760
• UDI-Public: (01)00884838086760
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 09/18/2026

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 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: 08/20/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 01/18/2023
• 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