inforMED
MalfunctionLHC

ORS-320 SLUSH WARMER DRAPE

Received Oct 5, 2016

Report 8043817-2016-00050 · MDR key 6000056

Device

Generic name

Fluid Warming And Slush Drapes

Model number

ORS-320

Lot number

D160681

Product problems

  • Hole In Material
  • Hole In Material
  • Melted

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Information
  • No Known Impact Or Consequence To Patient
  • No Information

Narrative

Additional Manufacturer Narrative

AT THE TIME OF THIS REPORT, THE DEVICE HAD NOT BEEN RETURNED FOR EVALUATION. THE DHR WAS REVIEWED AND THIS LOT WAS MANUFACTURED ON 03/08/2016 AND CONTAINED 2400 PCS. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. A PICTURE OF THE DEVICE WAS PROVIDED WHICH APPEARED TO SHOW A SPOT ON THE DRAPE THAT WAS MELTED. 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 MISUSE BY THE CUSTOMER, NO ADDITIONAL ACTIONS ARE BEING TAKEN AT THIS TIME. FOLLOW UP #1 THE DEVICE WAS RETURNED AND A SMALL BURN MARK ABOUT 15 INCHES FROM THE SLUSH PLATE ON THE WARMER SIDE WAS OBSERVED. THE DHR WAS REVIEWED AND THIS LOT WAS MANUFACTURED ON 03/08/2016 AND CONTAINED 2400 PCS. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. 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 MISUSE BY THE CUSTOMER, NO ADDITIONAL ACTIONS ARE BEING TAKEN AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A SPOT ON A SLUSH DRAPE THAT APPEARED TO BE MELTED TOGETHER.

Additional Manufacturer Narrative

AT THE TIME OF THIS REPORT, THE DEVICE HAD NOT BEEN RETURNED FOR EVALUATION. THE DHR WAS REVIEWED AND THIS LOT WAS MANUFACTURED ON 03/08/2016 AND CONTAINED 2400 PCS. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. A PICTURE OF THE DEVICE WAS PROVIDED WHICH APPEARED TO SHOW A SPOT ON THE DRAPE THAT WAS MELTED. 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 MISUSE BY THE CUSTOMER, NO ADDITIONAL ACTIONS ARE BEING TAKEN AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A SPOT ON A SLUSH DRAPE THAT APPEARED TO BE MELTED TOGETHER.