inforMED
MalfunctionLHC

ORS-320 SLUSH WARMER DRAPE

Received Oct 5, 2016

Report 8043817-2016-00051 · MDR key 6000340

Device

Generic name

Fluid Warming And Slush Drapes

Model number

ORS-320

Lot number

D161031

Product problems

  • Hole In Material
  • Hole In Material
  • Split

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. 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. FOLLOW UP #1: THE DEVICE WAS RETURNED AND A SMALL BURN MARK AND HOLE APPROXIMATELY 18 INCHES FROM THE SLUSH PLATE ON THE WARMER SIDE WAS OBSERVED. THE DHR WAS REVIEWED AND THIS LOT WAS MANUFACTURED ON 04/13/2016 AND CONTAINED 2,256 PIECES. 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 A DRAPE HAD A SLIT AND IT WAS USED ON THE NEW WARMER/SLUSH UNIT.

Additional Manufacturer Narrative

AT THE TIME OF THIS REPORT, THE DEVICE HAD NOT BEEN RETURNED FOR EVALUATION. 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.

Description of Event or Problem

IT WAS REPORTED THAT A DRAPE HAD A SLIT AND IT WAS USED ON THE NEW WARMER/SLUSH UNIT.