CALEO INCUBATOR

Description of Event or Problem

AS I PREPARED TO TEST AN INCUBATOR FROM NICU LAST WEEK (B)(6) 2013), I PLUGGED THE UNIT INTO AN OUTLET AFTER CHANGING A FUSE. THERE WAS A SPUTTERING SOUND, AND THEN LIGHT FLASHES AND SMOKE POURED OUT OF OPENINGS IN THE INCUBATOR. I QUICKLY UNPLUGGED THE UNIT AND WATCHED THE DEVICE FOR SOME TIME TO BE SURE THERE WAS NO RESIDUAL FIRE. I OPENED THE HOUSING A FEW DAYS LATER AFTER SMOKE SETTLED INSIDE AND DISCOVERED THE CAUSE WAS ACCUMULATED RESIDUE OF BABY FORMAL THAT HAD FOUND A WAY INTO A HIGH VOLTAGE AREA THAT SHOULD BE PROTECTED FROM SUCH ENTRY (DF). EVENT (B)(4) REPORTED TO PSN AS AN UNSAFE CONDITION ON (B)(6) 2013. THE RESULTS ARE (B)(4) INSPECTIONS SHOW VARIOUS DEGREES OF BUILDUP AND SOME DAMAGE. THE REMAINING 10 UNITS WILL BE INSPECTED TODAY ((B)(4) 2013). WE HAVE TAGGED THE DEFECTIVE UNITS AS UNSAFE. ANY DEVICE WITH EVIDENCE OF FLUID INTRUSION WILL BE REMOVED FROM SERVICE PENDING DRAGER MEDICAL'S RESPONSE.