ORS-320N SLUSH WARMER DISC DRAPE
Received Feb 22, 2018
Report 8043817-2018-00006 · MDR key 7290324
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-320NLot number
D170801
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
Description of Event or Problem
END USER REPORTED THAT THE DRAPE IS LEAKING. NO INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.
Additional Manufacturer Narrative
NO PHOTOS OR SAMPLES WERE PROVIDED. THE DHR WAS REVIEWED AND IT WAS NOTICED THAT THIS LOT HAD (B)(4) CASES THAT WERE MANUFACTURED ON 03/24/2017. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. BASED ON THE DEVICE HISTORY RECORD REVIEW, THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. BECAUSE A SAMPLE WAS NOT PROVIDED AND THE DEVICE HISTORY RECORD SHOWS NO DEFECTS REPORTED, THE NON CONFORMITY COULD NOT BE CONFIRMED. NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. FOLLOW UP 1: NOTE: THIS IS A NON STERILE PART THAT IS PROVIDED TO A KIT PACKER FOR FURTHER PACKAGING AND STERILIZATION. THE SAMPLE WAS RECEIVED FOR EVALUATION. A SMALL BURN MARK/HOLE WAS OBSERVED ABOUT 17 1/2 INCHES FROM THE SLUSH DISK. BASED ON THE DEVICE HISTORY RECORD AND 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.
Additional Manufacturer Narrative
NO PHOTOS OR SAMPLES WERE PROVIDED. THE DHR WAS REVIEWED AND IT WAS NOTICED THAT THIS LOT HAD 10 CASES THAT WERE MANUFACTURED ON (B)(6) 2017. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. BASED ON THE DEVICE HISTORY RECORD REVIEW, THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. BECAUSE A SAMPLE WAS NOT PROVIDED AND THE DEVICE HISTORY RECORD SHOWS NO DEFECTS REPORTED, THE NON CONFORMITY COULD NOT BE CONFIRMED. NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
END USER REPORTED THAT THE DRAPE WAS LEAKING. NO INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.