MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE PATIENT MONITOR MP5SC

Model Number	INTELLIVUE PATIENT MONITOR MP5SC
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis was performed by remote service personnel who talked to the customer.The customer explained that the issue as found during preventive maintenance.The remote support engineer (rse) asked how the it was determined that the blood pressure (nbp) measurements were inaccurate.The customer confirmed he was testing the simulator.The rse emailed customer excerpt from intellivue patient monitor service guide with nbp performance test procedures.Explained to customer that nbp can only be calibrated using static measurement as described in intellivue patient monitor service guide.Based on the results of the analysis, it was determined that the product has malfunctioned and the most likely cause of the reported problem was the valve.The issue was resolved by providing the customer with the part number to replace the defective part.The customer confirmed he will order the part and is taking responsibility for servicing the device.
Event or Problem Description
It was reported the device gives wrong blood pressure measurements (nibp) and will not calibrate even after the customer replaced the nibp pump assembly.The device was not in clinical use.There was no report of patient or user harm.

• Brand Name: INTELLIVUE PATIENT MONITOR MP5SC
• Common Device Name: INTELLIVUE PATIENT MONITOR MP5SC
• 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: 24330857
• Report Number: 9610816-2026-100291
• Device Sequence Number: 4811026
• Product Code: MHX
• UDI-Device Identifier: 00884838021884
• UDI-Public: (01)00884838021884
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K150310
• 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): 02/13/2026

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 PATIENT MONITOR MP5SC
• Device Catalogue Number: 865322
• 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: 01/23/2026
• Initial Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2019
• 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