MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE X3

Model Number 867030

Device Problem No Audible Prompt/Feedback (2282)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2024

Event Type  malfunction  

Manufacturer Narrative

A philips field service engineer (fse) performed diagnostic/functional testing and found the unit in good condition.Results of functional testing indicate that the device was functioning per specification and the issue was unable to be replicated.It was noted that the fault could have been caused by a host monitor or faulty multi measurement server (mms); however, this was not confirmed.Based on the information available and the testing conducted philips was unable to replicate the reported problem.The root cause was unable to be determined.

Event Description

The customer reported the intellivue x3 needs repair for a speaker malfunction.It is unknown if the device produced sound.The device was not in use on a patient at the time of the event, there was no patient involvement.

• Brand Name: INTELLIVUE X3
• Type of Device: INTELLIVUE X3
• 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 ; 7031463203
• MDR Report Key: 19086483
• MDR Text Key: 340593267
• Report Number: 9610816-2024-00189
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838082588
• UDI-Public: 00884838082588
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K171801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: 505
• Type of Report: Initial

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
• Device Operator: Health Professional
• Device Model Number: 867030
• Device Catalogue Number: 867030
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1