MalfunctionLHC
WARMETTE 48
Received Aug 26, 2016
Report 3018859-2016-00007 · MDR key 5908545
Device
Product problems
- Overheating of Device
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
DEVICE RETURN WAS REQUESTED FROM THE CUSTOMER FOR EVALUATION AND INVESTIGATION. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, SUPPLEMENTAL FOLLOW-UP WILL BE SUBMITTED.
Description of Event or Problem
CUSTOMER STATED THAT THEIR 13 YEARS OLD DEVICE OVERHEATED. DEVICE WAS SET AT 90 DEGREES, BUT WAS MEASURED AT 150 DEGREES.
Remedial action
- Other