MalfunctionEKM
THERMAPREP2 OVEN
Received May 26, 2021
Report 8031010-2021-00092 · MDR key 11891707
Device
Product problems
- Unintended Electrical Shock
- Unintended Electrical Shock
Patient
Not reported
- Electric Shock
- No Clinical Signs, Symptoms or Conditions
- Electric Shock
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION.
Additional Manufacturer Narrative
WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, IF THIS MALFUNCTION RECURRED, IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. THE DEVICE WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION.
Description of Event or Problem
IT WAS REPORTED THAT THE ASSISTANT GOT AN ELECTRIC SHOCK DURING USE OF A THERMAPREP 2 OVEN; NO INJURY RESULTED.