WARMETTE 20

Additional Manufacturer Narrative

THE CUSTOMER HAS BEEN ASKED TO ASSIST IN THE EVALUATION OF THIS DEVICE. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

CUSTOMER REPORTED THAT THE UNIT OVERHEATED AND THE BLANKETS WERE SMOKING AND SCORCHED. THE CUSTOMER REMOVED THE BLANKETS AND UNPLUGGED THE UNIT. THERE HAS BEEN NO REPORT OF DEATH OR SERIOUS INJURY.

Additional Manufacturer Narrative

ADDITIONAL QUESTIONS REGARDING THE EVENT AND THE WARMETTE UNIT'S MAINTENANCE HISTORY WERE ASKED BY NATUS TECHNICAL SERVICE ON MULTIPLE OCCASIONS, BUT THESE QUESTIONS WERE NOT ANSWERED. NATUS TECHNICAL SERVICE ADVISED THE COMPLAINANT TO RETURN THE DEVICE FOR EVALUATION, BUT THE DEVICE WAS NOT RETURNED. IN INTERVIEWING THE COMPLAINANT IT WAS DISCOVERED THAT THE WARMETTE'S TEMPERATURE CONTROL KNOB HAD BEEN BROKEN SINCE THE UNIT WAS RECEIVED IN 2013, BUT THE ISSUE HAD NOT BEEN PREVIOUSLY REPORTED TO NATUS. A REPLACEMENT TEMPERATURE CONTROL KNOB WAS SENT TO THE COMPLAINANT. ONCE THE REPLACEMENT TEMPERATURE CONTROL KNOB WAS INSTALLED, IT WAS REPORTED THAT THE WARMETTE UNIT WAS OPERATING PROPERLY. THERE WERE NO SIGNS OF OVERHEATING OR RESIDUE FOUND IN THE HEATING CABINET. NATUS TECHNICAL SERVICE MADE MULTIPLE REQUESTS FOR THE COMPLAINANT TO PERFORM THE TEST ENTITLED "TEMPERATURE MEASUREMENT" IN THE OLYMPIC WARMETTE MODEL 20 INSTRUCTION MANUAL IN ORDER TO VERIFY THE UNIT IS OPERATING WITHIN SPECIFICATIONS PRIOR TO PLACING THE UNIT BACK INTO SERVICE. THE COMPLAINANT REPORTED THAT THEY DID NOT PERFORM THE TEST.