WARMER DRAPE

Additional Manufacturer Narrative

ONE USED DRAPE WITH HOLES IN IT (LOT UNKNOWN) AND ONE UNOPENED DRAPE (LOT D162291) WERE RECEIVED FOR EVALUATION. IT WAS OBSERVED THAT THE USED DRAPE HAD ABOUT 4 BURN MARKS. THREE OF THEM ABOUT 17 INCHES FROM THE SLUSH PLATE AND ONE ABOUT 15 1/2 INCHES FROM THE SLUSH PLATE ON THE WARMER SIDE. THE UNOPENED DRAPE DID NOT HAVE ANY HOLES, BURNS, MARKS OR TEARS. THE DHR WAS REVIEWED FOR LOT D162291 AND IT WAS NOTICED THAT THIS LOT HAD (B)(4) AND IT WAS MANUFACTURED ON 08/17/16. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. BASED ON THE DEVICE HISTORY RECORD AND SAMPLE REVIEW, THIS 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

END USER REPORTED THREE ORS-320 DRAPES HAVE COME OUT OF THE PACKAGING WITH TWO HOLES ON THE DRAPE. IT WAS REPORTED THAT THE OUTSIDE PACKAGING WAS INTACT AND THESE OCCURRENCES ARE RECENT. FOR TWO OF THOSE DRAPES THE LOT NUMBER WAS NOT RECORDED. THE LAST ONE HAD A LOT NUMBER OF D162291. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.