Draeger Cited for Failing to Report Infant Burns

Draeger Medical Systems did not submit a medical device report (MDR) to the FDA after the company was notified of an infant being severely burned when a piece of a warming unit allegedly fell and landed on the baby, according to a July 9 Form 483 from an inspection of the company’s Telford, Pa., facility. The company also failed to submit MDRs after learning of other incidents involving its infant warmers.
The GMP Letter