ORS-320 SLUSH WARMER DRAPE
Received Aug 10, 2017 · Event occurred Jul 14, 2017
Report 8043817-2017-00019 · MDR key 6784577
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-320Lot number
D170451
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 BURN MARK/HOLE WAS OBSERVED ABOUT 14 INCHES FROM THE SLUSH PLATE. IT WAS NOTED THAT IT LOOKS TO HAVE BEEN CAUSED BY A GRADUATE OF SOME SORT. THE DHR WAS REVIEWED AND IT WAS NOTICED THAT THIS LOT HAD 2880 PIECES THAT WERE MANUFACTURED ON 02/14/2017 AND 02/15/2017. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. BASED ON THE DEVICE HISTORY RECORD AND SAMPLE REVIEW, THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. BECAUSE THIS APPEARS TO BE RELATED TO MISUSE BY THE CUSTOMER, NO ACTIONS ARE BEING TAKEN AT THIS TIME. 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.
Description of Event or Problem
END USER REPORTED THAT THE PLASTIC APPEARED TO BE DISTORTED OR MELTED AND A SMALL HOLE WAS DISCOVERED AFTER THE DEVICE WAS USED. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.