WHITEHALL MANUFACTURING
Received Jun 5, 2018 · Event occurred Mar 17, 2014
Report 1000150265-2018-00001 · MDR key 7571726
Device
Generic name
Thermo-therapy
Manufacturer
Whitehall ManufacturingModel number
TT-101Catalog number
TT-101
Lot number
NA
Product problems
- Device Operational Issue
- Device Operational Issue
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
EVALUATION OF THE RETURNED UNIT WAS PERFORMED IN WHITEHALL'S R&D LAB ON 4/14/2014. THE EVALUATION FOUND THAT THE UNIT HAD BEEN OPENED BY AN UNKNOWN PERSON AND WAS MODIFIED AS IT WAS NO LONGER ASSEMBLED PER MANUFACTURING STANDARDS WHICH MAY HAVE CAUSED THE MALFUNCTION. DEVICE WAS SCRAPPED AFTER EVALUATION. NO ADDITIONAL VERIFICATION OF THE MALFUNCTION CAN BE PERFORMED.
Description of Event or Problem
CUSTOMER CALLED WHITEHALL FIELD SERVICE TO REPORT THAT THEIR TT-101, THERMOTHERAPY UNIT WAS SHOWING A TEMPERATURE OF 200 DEGREES F AS WELL AS PRODUCING SMOKE. THE CUSTOMER REMOVED THE UNIT FROM SERVICE UPON FINDING THE MALFUNCTION. WHITEHALL REPLACED THE UNIT AT NO CHARGE AND BROUGHT THE UNIT IN QUESTION BACK FOR EVALUATION.
Remedial action
- Replace