MalfunctionLHC
WARMETTE 48
Received Sep 13, 2016
Report 3018859-2016-00010 · MDR key 5947704
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 REPORTED THAT THE LEFT CHAMBER OF HIS MODEL 55 WARMETTE WAS OVERHEATING. THERE WAS NO INJURY. TEMPERATURE SET WAS 100F, AND TEMPERATURE MEASURED WAS 121F. DEVICE RETURN WAS REQUESTED FOR INVESTIGATION.
Remedial action
- Other