MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER X2

Model Number	865039
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported an alarm issue.The device was not in use on a patient at the time of event, there was no adverse event reported.
Additional Manufacturer Narrative
E1: (b)(6).A philips authorized service provided (asp) went onsite to evaluate the device in question.The asp confirmed the customer's alleged malfunction and checked the system.The asp discovered the unit could not repeat inop with x2 standalone and then connected it to the bedside monitor to resolve the issue.The asp advised the customer to keep monitoring the unit further and report if the issue persisted.After a week, the customer had no alarm /error reported and so philips closed the case.Based on the information available and the testing conducted, the cause of the reported problem was confirmed to be the user did not have the x2 connected to the bedside monitor.The reported problem was confirmed.If additional information is received the complaint file will be reopened.No further investigation or action is warranted at this time.

• Brand Name: INTELLIVUE MULTI MEASUREMENT SERVER X2
• Common Device Name: INTELLIVUE MULTI MEASUREMENT SERVER X2
• 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: 23858446
• Report Number: 9610816-2025-001265
• Device Sequence Number: 13297980
• Product Code: MHX
• UDI-Device Identifier: 00884838000261
• UDI-Public: (01)00884838000261
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 12/20/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2016
• 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