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

Model Number 989605406772

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

Patient Problem Burn, Thermal (2530)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

Evaluation of the transducer will be included in a follow up report upon its return and investigation completion.

Event 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.

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
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• 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: 10345272
• Report Number: 3019216-2020-00047
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838061439
• UDI-Public: (01)00884838061439
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K043535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 989605406772
• Device Lot Number: B2HWWZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 07/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Outcome(s): Required Intervention