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	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: reporting address state: (b)(6), e1: reporting institution phone#: (b)(6), e1: reporter phone#: (b)(6).The philips remote service engineer (fse) talked to the customer and confirmed the device has no sound and displays a speaker malfunction inop error message.The rse arranged a replacement speaker assembly was sent to the customer to replace the defective speaker.Based on the information available and the testing conducted, the cause of the reported problem was a defective speaker.The reported problem was confirmed.The customer was provided with a replacement speaker assembly to resolve the reported issue.The device remains at customer site.The investigation concludes that no further action is required at this time.
Event or Problem Description
It was reported the device was presented with a speaker malfunction error message and there was no sound coming from the device.The device was not in use on a patient.There was no report of patient or user harm.

• 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: 23511087
• Report Number: 9610816-2025-001047
• Device Sequence Number: 9955490
• Product Code: DSI
• UDI-Device Identifier: 00884838000261
• UDI-Public: (01)00884838000261
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/10/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2018
• 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