inforMED
MalfunctionLHC

ORS-400 SCOPE PILLOW WARMER DRAPE

Received Aug 28, 2017

Report 8043817-2017-00022 · MDR key 6825186

Device

Generic name

Fluid Warming And Slush Drapes

Model number

ORS-400

Lot number

D171361

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

THE DHR WAS REVIEWED FOR LOT D171361 AND IT WAS NOTICED THAT THIS LOT HAD (B)(4) PIECES THAT WERE MANUFACTURED ON 05/16/17 AND 05/17/17. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTION. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. BASED ON THE DEVICE HISTORY RECORD THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS, OR MATERIAL ISSUE. AT THE TIME OF THIS REPORT, NO SAMPLE HAD BEEN PROVIDED. 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

PER COMPANY REPRESENTATIVE "CUSTOMER REPORTED FLUID IN BASIN DUE TO HOLE IN DRAPE. THIS IS THE CUSTOMERS 3RD ISSUE IN 3 WEEKS. AFTER INITIAL COMPLAINT, I ATTENDED A PROCEDURE TO MAKE SURE WARMER WAS DRAPED PROPERLY. NO EVIDENCE OF INCIDENTS 1&2, ONLY 1ST PERSON ACCOUNT. THIS, THE 3RD ISSUE THE STAFF SAVED THE DRAPE AND WARMER INFO. ASKED TO HAVE WARMERS SWAPPED OUT."