inforMED
MalfunctionLHC

WARMER DRAPE

Received May 7, 2018

Report 8043817-2018-00015 · MDR key 7492348

Device

Generic name

Fluid Warming And Slush Drapes

Model number

ORS-300

Lot number

D173059

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 INVESTIGATION. THE SAMPLE DRAPE WAS PLACED OVER A WARMER AND WATER WAS ADDED. THE DRAPE WAS LEFT ON THE WARMER FOR OVER 1 HOUR. NO LEAKS, TEARS, HOLES OR BURN MARKS WERE FOUND. THE DHR WAS REVIEWED FOR LOT D173059 AND IT WAS NOTICED THAT THIS LOT HAD 2736 PIECES THAT WERE MANUFACTURED ON 11/02/2017. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. BASED ON THE DEVICE HISTORY RECORD AND SAMPLE REVIEW, THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS, OR MATERIAL ISSUE AS NO LEAKS, TEARS, HOLES OR BURN MARKS WERE FOUND. SINCE THE REPORTED ISSUE WAS NOT FOUND REVIEW OF THE SAMPLE AND NO DEFECTS WERE REPORTED DURING QUALITY INSPECTION, NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME.

Description of Event or Problem

COMPANY REP REPORTED "DRAPE IS TEARING DURING CASES. DID NOT SPECIFY ORIGINS OF TEARING BUT THAT THEY CONSIDERED DOUBLE DRAPING AS A SOLUTION. I DID LET THEM KNOW THIS IS NOT A GOOD IDEA AND COULD LEAD TO MORE ISSUES." NO PATIENT INJURY OR TREATMENT WAS REPORTED.