ORS-100 FLUID WARMER DRAPE
Received Jul 25, 2017
Report 8043817-2017-00018 · MDR key 6741225
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-100Lot 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 LOT NUMBER WAS NOT PROVIDED SO A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. A SAMPLE WAS RECEIVED FOR EVALUATION. A BURN MARK ABOUT 4 INCHES FROM THE CENTER OF THE DRAPE WAS OBSERVED. IT WAS NOTED THAT IT LOOKED TO BE CAUSED BY A GRADUATE OF SOME SORT BEING PLACED IN THE BASIN. BASED ON THE SAMPLE REVIEW THIS DOES 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
END USER NOTICED A HOLE AT THE END OF THE PROCEDURE. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.
Additional Manufacturer Narrative
A LOT NUMBER WAS NOT PROVIDED SO A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. A SAMPLE WAS RECEIVED FOR EVALUATION. A BURN MARK ABOUT 4 INCHES FROM THE CENTER OF THE DRAPE WAS OBSERVED. IT WAS NOTED THAT IT LOOKED TO BE CAUSED BY A GRADUATE OF SOME SORT BEING PLACED IN THE BASIN. BASED ON THE SAMPLE REVIEW 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
END USER NOTICED A HOLE AT THE END OF THE PROCEDURE. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.