MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE PATIENT MONITOR MX100

Model Number	INTELLIVUE MX100
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips bench repair technician (brt) evaluated the device and determined that the non-invasive blood pressure (nibp) pump was leaking and required replacement.Based on the information available and the testing conducted, the cause of the reported problem is the nibp pump.The reported problem was confirmed.The brt replaced and calibrated the nibp pump, and the device was returned to the customer.Section e reporting institution phone #: (b)(6).
Event or Problem Description
Philips received a complaint on the philips intellivue mx100 indicating that the blood pressure values were incorrect.The device was in use on a patient at the time of the event.There was no adverse event reported.

• Brand Name: INTELLIVUE PATIENT MONITOR MX100
• Common Device Name: INTELLIVUE PATIENT MONITOR MX100
• 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: 23846607
• Report Number: 9610816-2025-001256
• Device Sequence Number: 18596264
• Product Code: MHX
• UDI-Device Identifier: 00884838082595
• UDI-Public: (01)00884838082595
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K171801
• 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): 12/19/2025

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 MX100
• Device Catalogue Number: 867033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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