MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER

Model Number	INTELLIVUE MULTI MEASUREMENT SERVER
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device gives inaccurate blood pressure (nibp) measurements.The device was in clinical use.There was no report of patient or user harm.
Additional Manufacturer Narrative
Analysis was performed by remote service personnel who talked to the customer.The results of the analysis were that the reported issue could not be confirmed.Based on the results of the analysis, the product was confirmed to be operating per specifications and the cause of the reported problem remains unknown.The issue was resolved by providing this information to the customer.A review of the service history for this device shows the problem has not been reported again for this device.E1: reporting address state: (b)(6).E1: reporting institution phone#:(b)(6).E1: reporter phone# :(b)(6).

• Brand Name: INTELLIVUE MULTI MEASUREMENT SERVER
• Common Device Name: INTELLIVUE MULTI MEASUREMENT SERVER
• 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: 24330956
• Report Number: 9610816-2026-100290
• Device Sequence Number: 13211282
• Product Code: DQA
• UDI-Device Identifier: 00884838000254
• UDI-Public: (01)00884838000254
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K090360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Literature,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: Health Professional
• Device Model Number: INTELLIVUE MULTI MEASUREMENT SERVER
• Device Catalogue Number: 862442
• 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: 01/22/2026
• Initial Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2017
• 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