inforMED

4TH GENERATION WARMING CABINET

Received Dec 23, 2013 · Event occurred Nov 11, 2013

Report 1043572-2013-00138 · MDR key 3533564

Device

Generic name

Warming Cabinet

Product problems

  • Smoking

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE SMELLED AND SAW SMOKE EMITTING FROM THE WARMING CABINET. THE EMPLOYEE OPENED THE DOOR TO THE WARMING CABINET AND SAW THE BLANKETS INSIDE WERE SMOKING. TO STOP THE SMOKING THE EMPLOYEE USED A FIRE EXTINGUISHER. THE FIRE ALARM WENT OFF AND THE FIRE DEPARTMENT WAS DISPATCHED. THE FIRE DEPARTMENT REMOVED THE WARMING CABINET FROM THE FACILITY AND NO INJURIES WERE REPORTED. PROCEDURAL DELAYS AND CANCELLATIONS WERE REPORTED.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE AND TOOK PICTURES OF THE WARMING CABINET. THE PICTURES EVIDENCED A DARK SPOT ON THE RIGHT SIDE OF THE UPPER COMPARTMENT WHERE AN IV BAG WAS. THERE WAS ALSO SOMETHING STUCK ON THE SIDE OF THE SHELF ASSEMBLY IN THE SAME SPOT. THE PICTURES FURTHER EVIDENCE THAT THE WARMING CABINET HAS SOME MODIFICATIONS SPECIFICALLY TO THE FRONT PANEL OF THE WARMING CABINET. THIS MODIFICATION WAS NOT CONDUCTED BY STERIS AND WAS AN UNAUTHORIZED MODIFICATION CONDUCTED BY THE USER FACILITY'S THIRD PARTY SERVICE PROVIDER. THE PICTURES ALSO EVIDENCE A DIGITAL DISPLAY/TEMPERATURE CONTROLLER THAT IS NOT ORIGINAL TO THE EQUIPMENT. THIS WAS ALSO AN UNAUTHORIZED MODIFICATION MADE BY THE USER FACILITY'S THIRD PARTY SERVICE PROVIDER. THE TECHNICIAN WAS ADVISED THAT THE WARMING CABINET WAS MISSING THE BLANKET SHELF. THE OPERATOR MANUAL STATES, "CAUTION-POSSIBLE EQUIPMENT DAMAGE: THE FOLLOWING ITEMS ARE ACCEPTABLE FOR PROCESSING IN THIS WARMING CABINET. IF IN DOUBT AS TO WHETHER AN ITEM CAN BE SAFELY PROCESSED, HAVE YOUR SUPERVISOR CONTACT THE MANUFACTURER OF THE ITEM TO DETERMINE THE MAXIMUM TEMPERATURE IT SAFELY WILL WITHSTAND." "MUSLIN OR COTTON SHEETS AND WOOL BLANKETS MAY BE PROCESSED. HOWEVER, IF THESE ITEMS ARE STACKED ONE UPON THE OTHER, ALLOW SUFFICIENT TIME TO HEAT THEM THROUGHOUT. LEAVE CLEARANCE AROUND THE LOAD FOR AIR CIRCULATION." THE OPERATOR MANUAL FURTHER STATES, "CAUTION-POSSIBLE EQUIPMENT DAMAGE: IF UPPER COMPARTMENT OF A TWO COMPARTMENT WARMING CABINET OR SINGLE COMPARTMENT IS ELECTRICALLY HEATED, THE BLANKET HEATER IS ADHERED DIRECTLY TO THE BOTTOM PLATE, AND IF BLANKETS OR SOLUTIONS ARE RESTING ON THE BOTTOM PLATE WHILE THE WARMING CABINET IS IN OPERATION, THEY WILL BECOME EXTREMELY HOT. A BLANKET ACCESSORY SHELF SHOULD BE USED TO PREVENT BLANKETS OR SOLUTIONS FROM GETTING TOO HOT." THE WARMING CABINET IS NOW IN POSSESSION WITH COAST TO COAST WHO IS THE THIRD PARTY WHO SERVICES AND MAINTAINS THE WARMING CABINET. THE SERIAL NUMBER INDICATES THE UNIT IS APPROXIMATELY 32 YEARS OLD.