ORS-300N SOLUTION WARMER DRAPE

Additional Manufacturer Narrative

THIS EVENT WAS ASSOCIATED WITH ITEM NUMBER OM-ORS-300 LOT NUMBER 1057020 AND IS ASSOCIATED WITH THE POTENTIAL FOLLOWING ORS-300N NON STERILE MICROTEK LOT NUMBERS, DA153151, D153151, D153151A AND D153061A. AFTER EXAMINING THE RETURNED DEVICE, THE "HOLE" IN QUESTION APPEARS TO BE A SMALL BURN HOLE. BASED ON THE DEVICE HISTORY RECORD AND SAMPLE REVIEW, THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A MANUFACTURING OR MATERIAL ISSUE. MELTS, THOUGH UNCOMMON, CAN OCCUR WHEN THE WARMER IS NOT DRAPED PROPERLY, NOT TURNED OFF BY USING THE POWER BUTTON, AND/OR THERE IS INSUFFICIENT FLUID IN THE WARMER BASIN, CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS. BASED UPON THE EXAMINATION OF THE RETURNED PRODUCT, IT IS CONCLUDED THAT THIS EVENT WAS RELATED TO MISUSE BY THE CUSTOMER AND THEREFORE NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME.

Description of Event or Problem

AFTER THE SURGICAL CASE WAS FINISHED, STAFF NOTICED THERE WAS SALINE BETWEEN THE DRAPE AND WARMER BASIN. UPON FURTHER INSPECTION THEY DETECTED A SMALL HOLE IN THE DRAPE. BIOMED INSPECTED THE WARMING UNIT AND FOUND IT TO PERFORM CORRECTLY.