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

Model Number	865039
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis was performed by onsite service personnel which included functional testing.The results of the analysis confirmed the cable connected to the speaker was broken.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 broken cable connecting the speaker.The issue was resolved by replacing the speaker assembly and the product is back in service.Based on the information available and results of additional analysis, no further action is necessary at this time.If additional information is received, the complaint file will be reopened for further investigation.
Event or Problem Description
Philips received a complaint on intellivue multi measurement server x2 indicating that while performing product training, a speaker equipment malfunction inop was displayed and there was no audible sound when the device was turned on.The device was not in use on patient at time of event, there was no adverse event reported.

• 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: 23450639
• Report Number: 9610816-2025-001020
• Device Sequence Number: 21059736
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2025

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: Other
• Device Model Number: 865039
• Device Catalogue Number: M3002A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2018
• 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