SKYTRON

Description of Event or Problem

SKYTRON HAS BEEN MADE AWARE OF A DEFECT WITH OUR WARMING CABINETS (BLANKET WARMERS). BLANKETS THAT ARE PLACED AGAINST THE REAR WALL OF THE CABINET ARE AT RISK OF BEING SCORCHED WITH THE POSSIBILITY OF A FIRE STARTING. SKYTRON REQUIRED JAMESTOWN METAL PRODUCTS TO PERFORM A RISK ANALYSIS AS WELL AS COMPLETE AN HHE AND A CAPA. THEY HAVE MANUFACTURED A RETROFIT TO RESOLVE THE ISSUE. WHILE A WARMER IS NOT A CLASSIFIED MEDICAL DEVICE AS IT IS STRICTLY FOR BLANKETS AND NOT INJECTABLES OR SOLUTIONS, WE WILL BE CONDUCTING A FIELD CORRECTION IN ORDER TO MAINTAIN THE SAFETY OF ANY PATIENTS AND STAFF THAT COME INTO CONTACT WITH THE CABINET. THE FIELD CORRECTION HAS BEEN COMPLETED.