ORS-188231 WARMER DRAPE WITH SKIRT
Received Aug 17, 2016
Report 8043817-2016-00043 · MDR key 5884277
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-188231Product problems
- Hole In Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AFTER EXAMINING THE RETURNED DEVICE, A SMALL BURN HOLE AT THE TOP OF THE DRAPE WAS NOTICED. BASED ON THE SAMPLE REVIEW, THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS 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
CUSTOMER NOTICED A HOLE IN THE DRAPE WHEN SOLUTION WAS IN THE DRAPE ON THE WARMER. THE CUSTOMER NOTICED SOLUTION BELOW THE DRAPE.