MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC EPIQ 7C - 795201; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number EPIQ 7C - 795201

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/25/2018

Event Type  Injury  

Manufacturer Narrative

An investigation to determine the cause of this issue is ongoing.Return of the transducer is anticipated; the failure analysis will be included in a follow-up report upon its return and investigation completion.

Event Description

A customer reported their epiq 7c system locked up while performing a tee (transesophageal) examination using an x7-2t model transducer.During the procedure, the doctor noted minor bleeding from the patient¿s esophagus, but could not determine when or how the bleeding occurred.The procedure was successfully completed using another ultrasound system and the patient received treatment in the ear, nose and throat department.The suspect transducer has been removed from service and will be replaced with another x7-2t transducer.Further information regarding the patient condition was not disclosed.

Manufacturer Narrative

The suspect x7-2t transducer returned to philips for further investigation.A thorough failure analysis was performed in which the probe passed all performance testing.There were no evident signs of holes in the sheath or corrosion in the connector, and the cable was capable of articulating fully while imaging.No system lockups or error messages were triggered throughout the evaluation and after repeated attempts with multiple operators and systems, the reported issue could not be reproduced.

• Brand Name: EPIQ 7C - 795201
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 7397604
• MDR Text Key: 104402566
• Report Number: 3019216-2018-00024
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K160807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EPIQ 7C - 795201
• Device Catalogue Number: EPIQ 7C - 795201
• Device Lot Number: B1FH5B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention