ORS-321 SLUSH WARMER DISC DRAPE
Received Oct 26, 2017
Report 8043817-2017-00029 · MDR key 6979429
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-321Lot 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
NO SAMPLES WERE RETURNED FOR THIS INVESTIGATION AND A LOT NUMBER WAS NOT PROVIDED TO PERFORM A DHR REVIEW. SINCE NO LOT NUMBER OR SAMPLE WAS PROVIDED THE NON CONFORMITY COULD NOT BE CONFIRMED. IT WAS NOT DETERMINED IF THIS ISSUE WAS RELATED TO 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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
AN END USER REPORTED THAT THE DRAPE HAD A MELT SPOT IN IT. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.