ORS-320 SLUSH WARMER DISC DRAPE

Additional Manufacturer Narrative

A SAMPLE WAS RECEIVED FOR EVALUATION. THE DRAPE HAD A SMALL HOLE 22 INCHES FROM THE SLUSH PLATE AND 7 INCHES TO THE LEFT. NOT WHERE THE DRAPE WOULD SIT IN THE BASIN. THE DHR WAS REVIEWED AND IT WAS NOTICED THAT THIS LOT HAD 2400 PCS THAT WERE MANUFACTURED ON 05/02/2017. NO DEFECTS RELATED TO THE NONCONFORMANCE WERE REPORTED DURING QUALITY INSPECTIONS. THE PERSONNEL WERE TRAINED. THE PRODUCTION LINE THIS PRODUCT WAS MANUFACTURED ON HAS SINCE BEEN DISCONTINUED. THE CURRENT PRODUCTION LINE WAS REVIEWED AND NOTHING WAS FOUND THAT COULD CREATE A HOLE IN THE DRAPE. ADDITIONALLY, THE METHOD AT THE CURRENT PRODUCTION LINE WAS REVIEWED AND IT WAS CONFIRMED THAT THE OPERATORS FOLLOW THE PROCESS. IT WAS CONCLUDED THAT THE SAMPLE SENT BY THE CUSTOMER CONFIRMED THE ORIGINAL COMPLAINT/DESCRIPTION OF THE PROBLEM. IN THE SAMPLE A PINCH WAS NOTICED AT THE HOLE. THIS PINCH RISES UP FROM THE BOTTOM PART OF THE DRAPE AND THIS INDICATES THAT THE EDGES OF THE OVEN (WARMER) WERE SHARP. THE LOCATION OF THE HOLE IS IN THE SAME AREA.

Description of Event or Problem

CLEANED AND DECONTAMINATED THE DRAPE SO THAT IT CAN BE HANDLED. WHEN WE DRAPED THE MACHINE THE HOLE WAS NEAR THE CORNER OF THE WARMER. HOWEVER, THERE WAS A LITER OF FLUID THAT LEAKED INTO THE WARMER BASIN. THE EDGES OF THE WARMER ARE SHARP AND SHE PLANS TO PUT SOME DUCT TAPE ON THE CORNERS TO SMOOTH THEM OUT UNTIL REPLACEMENTS ARE RECEIVED. WE AREN'T SURE THAT IS WHAT HAPPENED BUT ONE POSSIBILITY. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.