Description of Event or Problem · 1
THE DEVICE WAS USED TO MAINTAIN THE BODY TEMPERATURE OF A NEWBORN PT THAT WAS DELIVERED IN A HOME SETTING AND REQUIRED TRANSPORT TO A LOCAL HEALTHCARE FACILITY BY AMBULANCE. THE DEVICE WAS PLACED BEHIND THE NEWBORN SHORTLY AFTER ARRIVAL BY FIRST RESPONDERS. THE DEVICE WAS CONTINUED TO BE HELD IN PLACE BY MOTHER, AND LATER FATHER, UNTIL ARRIVAL OF TRANSPORT CREW. THE PT WAS THEN TRANSFERRED TO THE AMBULANCE AND PLACED ON THE STRETCHER AND RESTRAINED IN AN ACR, OR AMBULANCE CHILD RESTRAINT DEVICE, FOR APPROX 30 MINS. THE WARMING BLANKET WAS INSIDE OF THE ACR WITH A BARRIER BETWEEN THE BLANKET AND THE POSTERIOR OF THE NEWBORN FOR THE TRANSPORT. UPON ARRIVAL AT THE HEALTHCARE FACILITY, THE PT WAS FOUND TO HAVE A COMBINATION OF FULL AND PARTIAL THICKNESS BURNS TO THE BILATERAL SHOULDERS AND THE COCCYX AREA. TOTAL PERCENTAGE OF BURN WAS INITIALLY ESTIMATED TO BE BETWEEN 10-12%. FDA SAFETY REPORT ID# (B)(4).