WARMETTE

Additional Manufacturer Narrative

BOTH BIOMEDICAL TECHNICIANS IN CONTACT WITH TECH SUPPORT REPORTED THAT THERE WAS HEAT DAMAGE APPARENT ON THE GASKET BETWEEN PLENUM (INSIDE WHICH ARE THE HEATING ELEMENTS) AND BLOWER. WHEN AIRFLOW NO LONGER FLOWS TO THE PLENUM, HEAT WILL BUILD IN THE PLENUM AND GASKET. THE CUSTOMER REPORTED THAT THE THERMAL CUTOUT WAS NOT OPENED, WHICH CAUSE THE HEATERS TO DISENGAGE. THE CUSTOMER IS INSTRUCTED TO TEST ANNUALLY PER THE USER MANUAL 56948-IMA-EN0408O. A REPLACEMENT PART OF THE BLOWER MOTOR, A REQUIRED COMPONENT WAS SENT DUE TO NORMAL WEAR AND TEAR ON THE 11 YEAR OLD PRODUCT. ISSUE WAS RESOLVED. NO FURTHER EVALUATION IS NEEDED.

Description of Event or Problem

NATUS MEDICAL RECEIVED A COMPLAINT THAT ON (B)(6) 2017 THE WARMETTE HAD A BURNING SMELL. THE GASKET BETWEEN THE WARMETTE BLOWER AND PLENUM WAS DEFORMED. FOLLOW-UP QUESTIONNAIRE ON AUGUST 25TH, 2017 BIOMEDICAL TECHNICIAN RESPONDED THAT THE "UNIT DEVELOPED VOLUMES OF SMOKE INSIDE OF UNIT." NO REPORTED INJURY OR PATIENT INVOLVEMENT.