WARMER DRAPE
Received Feb 22, 2016
Report 8043817-2016-00018 · MDR key 5451870
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominacana, S.a.,Model number
ORS-300Lot number
UNKNOWN
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SAMPLE DRAPE WAS SOAKED IN BLEACH FOR 45 MINUTES TO 1 HOUR, RINSED, LET DRY, CHECKED USED SAMPLE AND TOOK PHOTOS. THEN VISUALLY CHECKED FOR HOLES OR LEAKS. NO HOLES, LEAKS OR TEARS WERE NOTED IN THE DRAPE. AFTER REVIEWING THE SAMPLE, IT HAS BEEN CONCLUDED THAT THE NON CONFORMITY (HOLE) IS A BURN. 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; AND/OR IF THE WARMER IS OPERATED CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS.
Description of Event or Problem
AN END USER REPORTED THAT THE DRAPES OM-ORS-300 WERE LEAKING DURING SCOPE WARMING PROCEDURES.