MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC S7-3T - 989605406771; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	989605406772
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	06/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation of the transducer will be included in a follow up report upon its return and investigation completion.
Event or Problem Description
A customer reported encountering an incident with their s7-3t transesophageal transducer during a pediatric surgical procedure for congenital heart disease.The patient¿s upper lip presented an apparent small burn where the transducer was positioned.This issue did not impact the outcome of the procedure.
Additional Manufacturer Narrative
The returned transducer was evaluated and after thorough inspection and testing, the transducer passed all tests and was confirmed to be functioning as designed.The results of our clinical investigation suggest that the reported injuries are most likely device related pressure ulcers (drpu) caused by prolonged pressure from the tee transducer in contact with the lip and/or skin.Surgery associated with tee transducers that lasts longer than two hours has been associated with pressure injuries (pi).This could ultimately lead to device related pressure ulcers especially with patients in pediatric intensive care units.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: S7-3T - 989605406771
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 10251806
• Report Number: 3019216-2020-00041
• Device Sequence Number: 19439454
• Product Code: ITX
• UDI-Device Identifier: 00884838061439
• UDI-Public: (01)00884838061439
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K043535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2020

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: 989605406772
• Device Lot Number: B2HWWZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/03/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 02/12/2021
• 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