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	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the ibp measurement is not reading accurately.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 which included that the remote support engineer (rse) walked the customer through the process of zeroing the ibp.The customer advised he was able to zero the ibp but when sets the pro sim cube simulator to 200 the ibp measurement goes way above the 300mmhg.The same bad test results happened with another mms.The customer checked with other test set up onsite and found the test cable was defective and needed replacement.The results of the analysis were that the mms needed zeroing to solve the reported issue while the test cable for the simulator needed replacement.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 device needed calibration.The issue was resolved by zeroing the device and it is back in service.A review of the service history for this device confirm the problem has not been reported again for this device.

• 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: 24663460
• Report Number: 9610816-2026-100570
• Device Sequence Number: 9344592
• Product Code: DQA
• UDI-Device Identifier: 00884838000254
• UDI-Public: (01)00884838000254
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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: 02/27/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2019
• 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