MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC TRANSDUCER X8-2T

Model Number	989605455171
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The service engineer tested the system and was able to confirm the reported problem.A visual inspection revealed deposits inside the transducer connector which caused a poor connection between the system and the transducer.After carefully removing the deposits and cleaning the contacts of the connector, the system and transducer passed all tests and resumed normal operation.Both the system and transducer remain in use at the customer site with no return anticipated; therefore, no further failure analysis can be performed.
Event or Problem Description
A customer reported encountering an incident where their epiq ultrasound system would not recognize the x8-2t tee model transducer during an elective aortic valve replacement.The failure occurred while the transducer was inserted in the patient, but prior to the bypass surgery.After rebooting the system twice, the transducer became fully functional and the procedure was successfully completed with no adverse effect to the patient.

• Brand Name: TRANSDUCER X8-2T
• Common Device Name: TRANSDUCER
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 9440524
• Report Number: 3019216-2019-00087
• Device Sequence Number: 400992
• Product Code: ITX
• UDI-Device Identifier: 00884838069718
• UDI-Public: (01)00884838069718
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K163120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2019

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: 989605455171
• Device Lot Number: B2XDCJ
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1