MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER X2; MULTIPLE VITAL PHYSIOLOGICAL PARAMETER MONITORING SYSTEM, CLINICAL

Model Number	865039
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that nbp value is strange.It is unknown if the device was in clinical use at the time of the event.No adverse event or patient harm was reported.
Additional Manufacturer Narrative
D4 model # was updated per gudid.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 a faulty nbp pump and parameter board.The issue was resolved by replacing the nbp pump and parameter board.The product was put back in service.Based on the information available and results of additional analysis, no further action is necessary at this time.

• Brand Name: INTELLIVUE MULTI MEASUREMENT SERVER X2
• Common Device Name: MULTIPLE VITAL PHYSIOLOGICAL PARAMETER MONITORING SYSTEM, CLINICAL
• 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: 23804495
• Report Number: 9610816-2025-001223
• Device Sequence Number: 7622298
• Product Code: MHX
• UDI-Device Identifier: 00884838000261
• UDI-Public: (01)00884838000261
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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: 865039
• Device Catalogue Number: 865039
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2017
• 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