THERMASURE

Additional Manufacturer Narrative

REASON FOR DELAY IN EMDR SUBMISSION: THIS EMDR REPORT WAS DELAYED IN SUBMISSION BECAUSE COMPUTER OF MANUFACTURER CONTACT WAS UPGRADED AND WAITING FOR NEW CERTIFICATE TO UPDATE ACCOUNT WITH FDA. THERE WERE DELAYS IN GETTING CERTIFICATE, TECHNICAL DIFFICULTIES WITH LOGGING INTO ACCOUNT, AND HAD TO RESUBMIT A NEW TEST SUBMISSION. CENORIN WAS ADVISED BY CDRH EMDR TO MAKE THE NOTATION IN THIS FIELD VIA EMAIL ON 12/30/2016. RECEIVED PRODUCTION ACCOUNT 01/23/2017. DURING THIS TIME, MORE INFORMATION WAS COLLECTED AND THE DEVICE WAS REPLACED WITH A NEW DEVICE. THE OLD DEVICE WAS RETURNED TO CENORIN FOR EVALUATION. EXPLANATION FOR CONCLUSION AND RESULT CODES IN THIS DOCUMENT: A REVIEW OF THE CHARRED TERMINAL BLOCK AND AN INSPECTION OF TERMINAL BLOCKS IN CENORIN INVENTORY SHOWED THAT THE MANUFACTURER OF THE TERMINAL BLOCK FAILED TO MEET THEIR OWN MANUFACTURING REQUIREMENTS OF SETTING PROPER TORQUE OF INTERFACING SCREWS WITH BLOCK. A REVIEW OF THE TERMINAL BLOCK DESIGN SHOWED DEFICIENCES IN THE DESIGN WHICH COULD RESULT IN TERMINAL BLOCK OVERHEATING AND CHARRING. BASED ON THE RESPONSE FROM THE FACILITY CONTACT ON 01/20/2017, THERE WERE NO SERIOUS INJURY OR ADVERSE EFFECTS ON THE USERS OF THE DRYER. THEY DID NOT REQUIRE MEDICAL ATTENTION. ON 02/01/2017 FOLLOW UP - BELOW IS A DESCRIPTION OF CHANGES: CORRECTED TYPE OF REPORTS FROM "5-DAY" TO "INITIAL". RECEIVED EMAIL FROM FDA ON 01/27/2017 ASKING IF THIS WAS TRULY A 5-DAY OR AN INITIAL 30-DAY REPORT. AFTER FURTHER REVIEW OF ALL INFORMATION, WE DECIDED THAT IT WAS BEST SUITED AS AN INITIAL 30-DAY. CORRECTED PHONE NUMBER IN INITIAL REPORTER TO (B)(6). DELETED FAX NUMBER. INITIAL PHONE INFORMATION WAS CENORIN CONTACT INFO.

Description of Event or Problem

AS OF (B)(6) 2016, CUSTOMER EMAILED STATING THAT TWO OF STAFF BECAME ILL FROM THE FUMES THAT THE DRYER WAS EMITTING. POSSIBLE ELECTRICAL COMPONENT OVERHEATED CAUSING CHARRING AND LIMITED TO INSIDE OF UNIT. CENORIN IS STILL INVESTIGATING ISSUE. AS OF (B)(6) 2017, CENORIN ENGINEERING EVALUATED THE UNIT AND VISUALLY FOUND THAT THE MAIN TERMINAL BLOCK THAT DISTRIBUTES POWER TO THE UNIT HAD FAILED AND DISPLAYED BURNT OR CHARRED RESIDUE.

Additional Manufacturer Narrative

(B)(4). DURING THIS TIME, MORE INFORMATION WAS COLLECTED AND THE DEVICE WAS REPLACED WITH A NEW DEVICE. THE OLD DEVICE WAS RETURNED TO CENORIN FOR EVALUATION. EXPLANATION FOR CONCLUSION AND RESULT CODES IN THIS DOCUMENT: A REVIEW OF THE CHARRED TERMINAL BLOCK AND AN INSPECTION OF TERMINAL BLOCKS IN CENORIN INVENTORY SHOWED THAT THE MANUFACTURER OF THE TERMINAL BLOCK FAILED TO MEET THEIR OWN MANUFACTURING REQUIREMENTS OF SETTING PROPER TORQUE OF INTERFACING SCREWS WITH BLOCK. A REVIEW OF THE TERMINAL BLOCK DESIGN SHOWED DEFICIENCES IN THE DESIGN WHICH COULD RESULT IN TERMINAL BLOCK OVERHEATING AND CHARRING. BASED ON THE RESPONSE FROM THE FACILITY CONTACT ON 01/20/2017, THERE WERE NO SERIOUS INJURY OR ADVERSE EFFECTS ON THE USERS OF THE DRYER. THEY DID NOT REQUIRE MEDICAL ATTENTION.

Description of Event or Problem

AS OF (B)(6) 2016, CUSTOMER EMAILED STATING THAT TWO OF STAFF BECAME ILL FROM THE FUMES THAT THE DRYER WAS EMITTING. POSSIBLE ELECTRICAL COMPONENT OVERHEATED CAUSING CHARRING AND LIMITED TO INSIDE OF UNIT. CENORIN IS STILL INVESTIGATING ISSUE. AS OF 1/24/2017, CENORIN ENGINEERING EVALUATED THE UNIT AND VISUALLY FOUND THAT THE MAIN TERMINAL BLOCK THAT DISTRIBUTES POWER TO THE UNIT HAD FAILED AND DISPLAYED BURNT OR CHARRED RESIDUE.