ORS-331 SLUSH WARMER DRAPE WITH PLATE
Received Dec 12, 2017
Report 8043817-2017-00033 · MDR key 7110751
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-331Lot number
UNKNOWN
Product problems
- Hole In Material
- Hole In Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A SAMPLE WAS RECEIVED FOR EVALUATION. A SMALL BURN MARK/HOLE WAS OBSERVED ABOUT 16 INCHES FROM THE SLUSH PLATE. NO LOT NUMBER WAS PROVIDED TO PERFORM A DEVICE HISTORY RECORD REVIEW. BASED ON THE SAMPLE EVALUATION 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. BECAUSE THIS APPEARS TO BE RELATED TO MISUSE BY THE CUSTOMER, NO ACTIONS ARE BEING TAKEN AT THIS TIME.
Description of Event or Problem
COMPANY REP REPORTED THAT (B)(6) IS STATING THAT THEY FOUND ABOUT AN INCH OF SALINE IN THE BOTTOM OF THE WARMER AFTER A SURGICAL CASE. THE HOSPITAL RECEIVED THE DRAPE THROUGH A CARDINAL KIT. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.