DEVICE SAFETY: Don't let radiant warmers overheat infants

March 2006 
Volume 36  Number 3
Pages 28 - 28
  PDF Version Available!



INFANT RADIANT WARMERS use infrared energy to maintain normal body temperature in infants who are critically ill or who need frequent procedures or treatment that requires prolonged exposure to a cool environment. If patients aren't closely monitored, however, these devices can cause potentially fatal hyperthermia and burns.

The Food and Drug Administration has received many medical device reports of injuries and deaths associated with radiant warmers that didn't alarm when overheating occurred. Here are two examples.

Case 1 . Before performing a procedure, a physician removed a skin temperature probe from an infant in a radiant warmer. When a warmer is in servo control mode, the skin temperature probe regulates the warmer to keep the infant's skin at a predetermined temperature. After removing the probe, the physician affixed it to the warmer post on the side of the unit while he did the procedure, then forgot to resecure the probe to the infant. Subsequently, ...

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