ORS-400 SCOPE PILLOW WARMER DRAPE
Received Aug 28, 2017
Report 8043817-2017-00024 · MDR key 6825488
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-400Lot 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
AT THE TIME OF THIS REPORT, NO LOT NUMBER OR SAMPLE HAD BEEN PROVIDED. AS NO DEVICE WAS AVAILABLE FOR EVALUATION, THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS IS REPORT 3 OF 3.
Description of Event or Problem
PER COMPANY REPRESENTATIVE "CUSTOMER REPORTED FLUID IN BASIN DUE TO HOLE IN DRAPE. THIS IS THE CUSTOMERS 3RD ISSUE IN 3 WEEKS. AFTER INITIAL COMPLAINT, I ATTENDED A PROCEDURE TO MAKE SURE WARMER WAS DRAPED PROPERLY. NO EVIDENCE OF INCIDENTS 1&2, ONLY 1ST PERSON ACCOUNT. THIS, THE 3RD ISSUE THE STAFF SAVED THE DRAPE AND WARMER INFO. ASKED TO HAVE WARMERS SWAPPED OUT."