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

Model Number	989605414121
Health Effect - Clinical Codes	Abrasion (1689); Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A field service representative went to the customer site and tested all of their x7-2t model transducers.All x7-2t model transducers passed testing, no product malfunction was identified, and no transducer return is anticipated.Since the transducer passed testing and is not being returned, no additional evaluation can be performed.
Event or Problem Description
A customer reported an incident where a patient sustained an injury during an examination with an x7-2t model transducer.Upon completion of a transesophageal exam, a gastrointestinal scope was used to identify blood on the esophageal wall.Further investigation by the customer found the patient had received an abrasion to their esophagus.The injury was treated topically and no additional medical intervention was required.

• 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: 8667057
• Report Number: 3019216-2019-00024
• Device Sequence Number: 1968469
• Product Code: ITX
• UDI-Device Identifier: 00884838061668
• UDI-Public: (01)00884838061668
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2019

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: B1FHCD
• 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: 05/23/2019
• Initial Report FDA Received Date: 06/04/2019
• 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: Other