WARMING CABINET BW7924TS

Additional Manufacturer Narrative

AFTER A THOROUGH EVALUATION OF THE RECORDS RELATED TO BLANKET WARMER (BW) SERIAL NUMBER# (B)(4), THE FOLLOWING WAS CONCLUDED: BASED ON OUR INVESTIGATION PERFORMED, WE CONCLUDE THIS EVENT IS AN END-USER RELATED ERROR. ACCORDING TO THE END-USER, BLANKETS WERE STUFFED IMPROPERLY INSIDE THE WARMER, BLOCKING USER'S SIGHT LINES OF PANELS AND OTHER COMPONENTS OF THE WARMERS. THIS MAY HAVE LED TO USER REACHING AREAS NOT INTENDED FOR USER CONTACT (E.G., INSIDE VENT HOLES) IN SOME SITUATIONS. ALTHOUGH OUR INVESTIGATION CONCLUDES THAT THE EVENT RELATES TO USER ERROR, WE NOTE THAT CHANGES INITIATED AS PART OF THE BLICKMAN CONTINUOUS IMPROVEMENT PROCESS WOULD ALSO ADDRESS THIS ISSUE FOR NEWER MODELS OF BLANKET WARMERS. BLICKMAN IMPLEMENTED AN IMPROVED DEBURRING STEP TO BW MANUFACTURING ON 05-26-11. THE INTENTION OF THIS ADDITIONAL STEP WAS TO FURTHER REDUCE THE PROBABILITY THAT A SHARP EDGE COULD OCCUR DURING THE PUNCH-HOLE PROCESS. CONSIDERING THAT BLICKMAN HAS NOT RECEIVED A SINGLE INJURY OR COMPLAINT SINCE THE IMPLEMENTATION OF THIS ADDITIONAL STEP IN THE MANUFACTURING PROCESS, WE CONSIDER IT TO BE PROVEN EFFECTIVE. AFTER REVIEWING THE DATE OF MANUFACTURE FOR THE UNIT REFERENCED, IT WAS BUILT PRIOR TO THE NEW PROCESS IMPROVEMENT IMPLEMENTATION. THIS IS THE SECOND COMPLAINT OF ANY KIND OF INJURY BLICKMAN HAS RECEIVED WITHIN A TEN-YEAR PERIOD FOR BLANKET WARMERS, WHICH REPRESENTS A (B)(4) DEFECT RATE OF THE UNITS SOLD IN THE SAME PERIOD. (NO FURTHER INFORMATION IS AVAILABLE ABOUT THE SECOND COMPLAINT AS WE WERE UNABLE TO CONTACT THE INDIVIDUAL.) NO TREND OF THIS TYPE OF EVENT HAS BEEN FOUND OR ESTABLISHED FOR BW UNITS MANUFACTURED BY BLICKMAN PRIOR TO OR AFTER THE CONTINUOUS IMPROVEMENT PROCESS WAS IMPLEMENTED. FOR THIS REASON, NO ADDITIONAL ACTION BY BLICKMAN IS RECOMMENDED. BASED ON THE FREQUENCY OF THE EVENTS REPORTED AS COMPLAINTS, END-USER SAFETY IS NOT EXPECTED TO BE ADVERSELY IMPACTED WHILE OPERATING BLICKMAN'S BLANKET WARMERS. AS A RESULT OF THIS THOROUGH INVESTIGATION, BLANKET WARMERS RELEASED THROUGH TODAY ARE RECOMMENDED TO MAINTAIN THEIR CURRENT DISPOSITION STATUS OF RELEASED. THE EMDR REPORT SUBMISSION TOOK LONGER THAN EXPECTED TO BE COMPLETED, DUE TO A FDA WEBTRADER SYSTEM NEW ACCOUNT SET UP DALAY. FOR ADDITIONAL INFORMATION, REFER TO FDA WEBTRADER SUPPORT COMMUNICATIONS. [MEDWATCH NOTIFICATION - MW5076055 .PDF]

Description of Event or Problem

STAFF MEMBER REACHED INSIDE OF TOP SHELF WARMER TO RETRIEVE BLANKET. HIS RIGHT MIDDLE FINGER GOT CAUGHT IN ONE OF THE VENT HOLES, CUTTING IT OPEN. STAFF RECEIVED MEDICAL ATTENTION IN THE EMERGENCY DEPARTMENT AFTER 15 MINUTES OF CONTINUOUS BLEEDING. SAFETY INCIDENT REPORT SUBMITTED THROUGH HOSPITAL LEADERSHIP.