WARMETTE 40
Received Oct 13, 2016
Report 3018859-2016-00020 · MDR key 6027484
Device
Product problems
- Overheating of Device
- Temperature Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE RETURN IS ANTICIPATED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT WHILE THE FIELD TECHNICIAN, WAS PERFORMING MAINTENANCE ON THE UNIT, HE NOTICED THAT THE TEMPERATURE WAS IN EXCESS OF THE SET TEMP. PER THE TECHNICIAN, HE SET THE TEMPERATURE AT 120 DEGREES, BUT IT MEASURED AT (131-132) DEGREES, WHICH WAS NOTED TO BE BEYOND THE 10 DEGREES TOLERANCE. NO ADVERSE PATIENT HARM WAS REPORTED. FAULTY PART RETURN HAS BEEN REQUESTED FOR FURTHER INVESTIGATION.
Additional Manufacturer Narrative
THE WARMETTE 40 UNIT WAS NOT RETURNED. BECAUSE THE UNIT HAD BEEN DISCONTINUED, THE COMPLAINANT WAS INFORMED THAT NATUS NO LONGER PROVIDES SERVICE OR REPLACEMENT PARTS FOR THE UNIT. THE COMPLAINANT DID RESPOND TO A LIST OF QUESTIONS REGARDING THE UNIT SENT AFTER THE INITIAL REPORT. THE COMPLAINANT STATED THAT THE FAN WAS WORKING PROPERLY AND THE LINT FILTER IS CLEANED MONTHLY AS PART OF A REGULAR PREVENTIVE MAINTENANCE SCHEDULE. THE ISSUE HAD BEEN FOUND DURING PREVENTIVE MAINTENANCE. THE UNIT WAS OPERATING IN 72 DEGREE CONDITIONS AT NORMAL HUMIDITY AND HAD BEEN OPERATED CONTINUOUSLY. BASED ON THE COMPLAINANT'S REPORT REGARDING THE CONDITION OF THE FAN, THE AGE OF THE UNIT, AND THE EXPERIENCE OF NATUS TECHNICAL SERVICE WITH SIMILAR ISSUES, PROBABLE CAUSE WAS ASSIGNED AS A FAILURE OF THE THERMOSTAT.