MAUDE Adverse Event Report: PHILIPS ULTRASOUND EPIQ CVXI; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported their epiq cvxi ultrasound system would not recognize a transducer on three of the four ports and produced image artifacts from the functional port during aortic heart valve replacement surgery.The surgery was unable to be completed using the suspect transducer and system.Repair of the system and investigation into the patient outcome are currently under evaluation.
Additional Manufacturer Narrative
The evaluation of system logs and any suspect replaced parts is currently underway.Results from the event evaluation and system repair will be included in a follow up report upon investigation completion.
Additional Manufacturer Narrative
A thorough investigation was performed, including analysis of the returned acquisition module, to identify the root cause of the reported issue.The engineering team confirmed that the error was not reproducible.However, repair services did note the connectors on the acquisition module were so dirty they caused noise/cannot detect transducer issues.As a correction, they cleaned the connectors.The replacement of the acquisition resolved the immediate issue.No further issues reported.
Event or Problem Description
A customer reported their epiq cvxi ultrasound system would not recognize a transducer on three of the four ports and produced image artifacts from the functional port during aortic heart valve replacement surgery.The surgery was unable to be completed using the suspect transducer and system.Repair of the system and investigation into the patient outcome are currently under evaluation.

• Brand Name: EPIQ CVXI
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: eric nail ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 14194021
• Report Number: 3019216-2022-00049
• Device Sequence Number: 11873996
• Product Code: IYN
• UDI-Device Identifier: 00884838097940
• UDI-Public: 00884838097940
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K132304
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795232
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2021
• 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