ELITE CARE CLINER W/SWING AWAY ARMS

Description of Event or Problem

ON (B)(6) 2014 WINCO CUSTOMER SVC REC'D A CALL FROM (B)(6), AREA TECH OPERATIONS MGR FOR FRESENIUS MEDICAL CARE. HE INFORMED US THAT A 6940 ELITE CARE CLINER HAD OVERHEATED DURING A PT TREATMENT AND LEFT A BURN PATTERN ON THE CHAIR BACK CUSHION AND THE PTS PILLOW. THE PT INITIALLY HAD RED MARKS ON HIS BACK SIMILAR TO A SUNBURN. THE PT REFUSED TO GO TO THE HOSP. UPON COMPLETION OF DIALYSIS, THE PT HAD ONLY A SMALL RED MARK ON HIS BACK. PT REC'D NO MEDICAL CARE FOR THE RED MARKS (B)(4).THE FACILITY REFUSED REPEATED REQUESTS FROM WINCO TO RETURN THE RECLINER FOR EVAL FOR APPROXIMATELY ONE MONTH.

Additional Manufacturer Narrative

THE FACILITY CONTACTED WINCO ABOUT THE INCIDENT, BY PHONE, ON 12/31/2014 BUT REFUSED TO RETURN THE CHAIR TO WINCO FOR EVAL UNTIL 01/29/2015. THIS IS THE "BECOMES AWARE" DATE THAT WE USED. ON 02/27/2015, ADVISED CLINIC TO INSPECT THEIR REMAINING RECLINERS FOR WORN OR INCORRECTLY INSTALLED WIRING HARNESS.