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.
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