MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC Transducer X7-2t; ULTRASOUND

Model Number	989605414121
Health Effect - Clinical Code	Perforation (2001)
Date of Event	05/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A thorough inspection with functional and safety tests of the involved transducer was performed by the local philips service engineer.Proper functionality of the transducer was confirmed and the device remains at the customer site.Since a return of the transducer is not expected, no additional device analysis can be performed.
Event or Problem Description
A customer reported detecting a perforated esophagus after performing a transesophageal (tee) examination using an x7-2t model transducer with an epiq ultrasound system.The procedure was completed without any observed harm to the patient.The injury was noticed the next day, and the patient received treatment for the perforated esophagus.Further information regarding the patient condition post procedure was not disclosed and the device remains at the customer site.

• Brand Name: Transducer X7-2t
• Common Device Name: ULTRASOUND
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 8717966
• Report Number: 3019216-2019-00031
• Device Sequence Number: 2073037
• Product Code: ITX
• UDI-Device Identifier: 00884838061668
• UDI-Public: (01)00884838061668
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K030455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 989605414121
• Device Lot Number: B1ZGZ6
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 112