SOLUTION WARMER

Additional Manufacturer Narrative

THE DEFECTIVE UNIT WAS RECEIVED AT MFG-ONE (MFG-ONE IS A MANUFACTURING CONTRACTOR FOR (B)(4)) ON 2/24/16. AFTER THE EVALUATION OF THE SLUSH MACHINE, MFG-ONE MANUFACTURER WAS ABLE TO CONFIRM THE INITIAL COMPLAINT THAT THE UNIT DID NOT COOL OR MAKE SLUSH AND AN AUDIBLE CLICK WAS HEARD EVERY 5-10 SEC. SINCE THE UNIT WAS FULLY TESTED PER MFG-ONE PROCEDURES DURING INITIAL PRODUCTION AND SOLD TO (B)(4); MFG-ONE WAS CONFIDENT THAT THE COMPRESSOR WAS NOT FAULTY AND THERE WERE NO WORKMANSHIP ISSUES DURING THE UNIT BUILD PROCESS. THE CONTRIBUTING FACTOR THAT WILL CAUSE THE COMPRESSOR TO SEIZE IS THAT IF THE UNIT IS LAID DOWN ON ITS BACK FOR A PERIOD OF TIME. THIS WILL ALLOW THE OIL IN THE COMPRESSOR TO MIGRATE INTO THE COILS AND NOT RETURN BACK INTO THE COMPRESSOR TO LUBRICATE THE VALVES. THE UNIT WILL FUNCTION FOR A WHILE AND THEN EVENTUALLY STOP WORKING - THIS IS EXACTLY THE SCENARIO THAT TOOK PLACE AT THE VA HOSPITAL. DURING EVALUATION IN HOUSE, THE UNIT DOES NOT COOL AND THE COMPRESSOR BECOMES VERY HOT TO THE TOUCH IN LESS THAN A MINUTE. FOLLOW UP #1: BASED ON THE REVIEW OF THE SLUSH MACHINE, THIS ISSUE DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS, OR MATERIALS ISSUE. NO ADDITIONAL ACTIONS WERE TAKEN.

Description of Event or Problem

A PAIR OF SLUSH MACHINES WERE RECENTLY DELIVERED. DURING A 6 HOUR OPEN HEART CASE ONE OF THE NEW UNITS STOPPED COOLING AND ALL OF THE SLUSH MELTED. NO PATIENT INJURY OR TREATMENT WAS REPORTED.

Additional Manufacturer Narrative

THE DEFECTIVE UNIT WAS RECEIVED AT (B)(4) ((B)(4) IS A MANUFACTURING CONTRACTOR FOR MICROTEK-ECOLAB) ON 02/24/2016. AFTER THE EVALUATION OF THE SLUSH MACHINE, (B)(4)MANUFACTURER WAS ABLE TO CONFIRM THE INITIAL COMPLAINT THAT THE UNIT DID NOT COOL OR MAKE SLUSH AND AN AUDIBLE CLICK WAS HEARD EVERY 5-10 SEC. SINCE THE UNIT WAS FULLY TESTED PER (B)(4) PROCEDURES DURING INITIAL PRODUCTION AND SOLD TO ECOLAB; (B)(4) CONFIDENT THAT THE COMPRESSOR WAS NOT FAULTY AND THERE WERE NO WORKMANSHIP ISSUES DURING THE UNIT BUILD PROCESS. THE CONTRIBUTING FACTOR THAT WILL CAUSE THE COMPRESSOR TO SEIZE IS THAT IF THE UNIT IS LAID DOWN ON ITS BACK FOR A PERIOD OF TIME. THIS WILL ALLOW THE OIL IN THE COMPRESSOR TO MIGRATE INTO THE COILS AND NOT RETURN BACK INTO THE COMPRESSOR TO LUBRICATE THE VALVES. THE UNIT WILL FUNCTION FOR A WHILE AND THEN EVENTUALLY STOP WORKING - THIS IS EXACTLY THE SCENARIO THAT TOOK PLACE AT THE (B)(6) HOSPITAL. DURING EVALUATION IN HOUSE, THE UNIT DOES NOT COOL AND THE COMPRESSOR BECOMES VERY HOT TO THE TOUCH IN LESS THAN A MINUTE.

Description of Event or Problem

PAIR OF SLUSH MACHINES WERE DELIVERED TO (B)(6) MEDICAL CENTER. DURING A 6 HOUR OPEN HEART CASE ONE OF THE NEW UNITS STOPPED COOLING AND ALL OF THE SLUSH MELTED.