ORS-100 SOLUTION WARMER DRAPE
Received Jun 23, 2016
Report 8043817-2016-00037 · MDR key 5745077
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-100Lot number
D160261
Product problems
- Hole In Material
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
AFTER EXAMINING THE RETURNED DEVICE, THE "HOLE" IN QUESTION APPEARS TO BE A CRESCENT SHAPED 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
A WARMER DRAPE THAT WAS USED DURING A PROCEDURE HAS A HOLE IN IT.