MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP5

Model Number	INTELLIVUE MP5
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis was performed by onsite service personnel which included carrying out blood pressure accuracy test and performance testing of the blood pressure measurement with blood pressure simulator according to the service guide.The results of the analysis were that the blood pressure measurement reading were in range and no problem was detected.Based on the results of the analysis, the product was confirmed to be operating per specifications and the cause of the reported problem could not be confirmed and remains unknown.The issue was resolved by performing nbp accuracy checks.The device is back into service.A review of the service history for this device shows the problem has not been reported again for this device.
Event or Problem Description
It was reported the intellivue mp5 spot check monitor is reading everyone's blood pressure (nbp) to high.The device was in clinical use.There was no report of patient or user harm.

• Brand Name: INTELLIVUE MP5
• Common Device Name: INTELLIVUE MP5
• 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: 24617772
• Report Number: 9610816-2026-100524
• Device Sequence Number: 21228885
• Product Code: MHX
• UDI-Device Identifier: 00884838000230
• UDI-Public: (01)00884838000230
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/17/2026

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 MP5
• Device Catalogue Number: 865024
• 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: 02/18/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2018
• 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