Bunnell increases QA checks on ventilator temperature gauge to address FDA concerns.
This article was originally published in The Gray Sheet
Executive Summary
BUNNELL QA CHECKS ON VENTILATOR TEMPERATURE GAUGE INCREASED in response to an Oct. 3 FDA warning letter to the Salt Lake City-based company. The firm has increased from one to two the number of quality assurance checks on the "thermoster" component of its high frequency jet ventilators to ensure that the temperature output of the ventilators remains within the range called for in Bunnell's design specifications.