inforMED
MalfunctionLHC

ORS-100 FLUID WARMER DRAPE

Received Jan 9, 2018

Report 8043817-2018-00001 · MDR key 7174987

Device

Generic name

Fluid Warming And Slush Drapes

Model number

ORS-100

Lot number

D172019

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. THE DRAPE WAS OBSERVED TO HAVE A BURN MARK WITH ABOUT THREE SMALL HOLES ABOUT 2 1/2 INCHES FORM THE CENTER OF THE DRAPE. IT LOOKED TO BE CAUSED BY A GRADUATE OF SOME SORT. THE DHR WAS REVIEWED AND IT WAS NOTICED THAT THIS LOT HAD (B)(4) PCS THAT WERE MANUFACTURED FROM 07/20/2017 TO 7/21/2017. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTION. BASED ON THE DHR AND SAMPLE REVIEW THIS ISSUE 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

AT THE END OF THE CASE, THE CUSTOMER NOTICED THAT THERE WAS FLUID IN THE BOTTOM OF THE WARMER. SHE NOTICED A HOLE IN THE DRAPE THAT DID NOT APPEAR TO BE CAUSED BY THE WARMER BURNING A HOLE IN THE DRAPE. SHE BELIEVES THAT THE DRAPE WAS DEFECTIVE. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.