inforMED
MalfunctionLSB

WHITEHALL MANUFACTURING

Received Jun 5, 2018 · Event occurred Mar 17, 2014

Report 1000150265-2018-00001 · MDR key 7571726

Device

Generic name

Thermo-therapy

Model number

TT-101

Catalog 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