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

Model Number 989605414121

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abrasion (1689); Injury (2348)

Event Type  Injury  

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 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
• Type of Device: ULTRASOUND
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: paul corrigan ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 8667057
• MDR Text Key: 146945358
• Report Number: 3019216-2019-00024
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838061668
• UDI-Public: (01)00884838061668
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K030455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 989605414121
• Device Lot Number: B1FHCD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other