MalfunctionLHC
INTRATEMP
Received Jun 29, 2018 · Event occurred May 31, 2018
Report 7650768 · MDR key 7650768
Device
Product problems
- Overheating of Device
Patient
4015 DA
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE BASIN FLUID WARMER SIDE POCKETS BECAME VERY HOT YET THE DIGITAL DISPLAY INDICATED 107 DEGREES F. THE TWO SIDE "BOTTLE POCKETS" ARE NOT TO EXCEED 110 DEGREES F. WE HAVE FOUND THAT THE BOTTLE TEMPERATURE CAN REACH 130 DEGREES F WHEN THE BOTTLE IS NOT RESTING OVER THE TEMPERATURE SENSOR. VARIOUS SIZE SOLUTION BOTTLES MAY BE PLACED INTO THESE POCKETS. THE SMALLER BOTTLES CAN BE PLACED IN THE POCKET SUCH THAT IT IS NOT RESTING OVER THE TEMPERATURE SENSOR. WHEN THE SENSOR IS NOT TOUCHING THE SIDE OF THE SOLUTION BOTTLE IT OVERHEATS THE BOTTLE.