WARMER DRAPE
Received Mar 24, 2016 · Event occurred Jan 22, 2016
Report 8043817-2016-00026 · MDR key 5523111
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-100NLot number
SEE H10
Product problems
- Melted
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
PRODUCT SAMPLE WAS RECEIVED ON 3/4/2016 AND REVIEWED ON 3/11/2016 BY QUALITY DEPARTMENT. THE DRAPE WAS SOAKED IN BLEACH WATER FOR 2 HOURS, RINSED, LET DRY, EXAMINED AND PICTURES TAKEN. THREE BURN MARKS WERE CIRCLED TO THE LEFT OF THE CENTER. ONE BURN MARK WAS AT 4 INCHES FROM THE TOP LEFT OF CENTER, 1 WAS AT 4 INCHES FROM THE LEFT OF CENTER AND 1 WAS AT ABOUT 4 1/2 INCHES FROM THE BOTTOM LEFT OF CENTER. WATER HAS BEEN ADDED TO DRAPE TO SEE IF DRAPE HAD ANY LEAKS. NO LEAK WAS FOUND ON DRAPE. THE SAMPLE DRAPE ONLY HAD BURN MARKS, THERE WAS NO BURN HOLE. 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 WARMER IS OPERATED CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS.
Description of Event or Problem
THE IRRIGATION WARMING DRAPE MELTED. FOUND AFTER THE CASE, DID NOT MELT ALL THE WAY THROUGH. NO PATIENT INJURY OR SAFETY CONCERNS.
Additional Manufacturer Narrative
PRODUCT SAMPLE WAS RECEIVED ON 3/4/2016 AND REVIEWED ON 3/11/2016 BY QUALITY DEPARTMENT. THE DRAPE WAS SOAKED IN BLEACH WATER FOR 2 HOURS, RINSED, LET DRY, EXAMINED AND PICTURES TAKEN. THREE BURN MARKS WERE CIRCLED TO THE LEFT OF THE CENTER. ONE BURN MARK WAS AT 4 INCHES FROM T HE TO LEFT OF CENTER, 1 WAS AT 4 INCHES FROM THE LEFT OF CENTER AND 1 WAS AT ABOUT 4 1/2 INCHES FROM THE BOTTOM LEFT OF CENTER. WATER HAS BEEN ADDED TO DRAPE TO SEE IF DRAPE HAD ANY LEAKS. NO LEAK WAS FOUND ON DRAPE. THE SAMPLE DRAPE ONLY HAD BURN MARKS, THERE WAS NO BURN HOLE. 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 WARMER IS OPERATED CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT, AND IN-SERVICE PRESENTATIONS.
Description of Event or Problem
THE IRRIGATION WARMING DRAPE MELTED. FOUND AFTER THE CASE, DID NOT MELT ALL THE WAY THROUGH. NO PATIENT INJURY OR SAFETY CONCERNS.