CHATTANOOGA
Received Mar 15, 2016 · Event occurred Nov 10, 2015
Report 9616086-2016-00008 · MDR key 5501616
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Electric Shock
- Electric Shock
Narrative
Additional Manufacturer Narrative
NOT YET RETURNED.
Description of Event or Problem
COMPLAINT RECEIVED THAT ALLEGES "ONCE TECHNICIAN BELIEVED THE THERAPY SESSION WAS COMPLETED SHE ATTEMPTED TO REMOVE THE ELECTRODES FROM THE PATIENT. AS SHE WAS REMOVING THE ELECTRODES SHE SUSTAINED AN ELECTRICAL SHOCK THAT GRIPPED HER HANDS, WRISTS AND ELBOWS SUSTAINED IT IN A FLEXED POSITION. SHE WAS UNABLE TO RELEASE THE ELECTRODES UNTIL THE MACHINE WAS SHUT OFF BY OTHERS IN THE ROOM". DEVICE NOT YET RETURNED TO MANUFACTURER FOR EVALUATION. NO INDICATION EVENT CAUSED OR CONTRIBUTED TO PERMANENT IMPAIRMENT OR DEATH.
Description of Event or Problem
PRODUCT WAS RETURNED FOR REVIEW. WHEN TESTING THE UNIT IN THE METHOD OF USE DEFINED BY THE CUSTOMER IN THE COMPLAINT, NO PROBLEMS WERE DUPLICATED. FOLLOWING FULL UNIT SPECIFICATION TESTING OF THE UNIT NO PROBLEMS WERE DUPLICATED. THE UNIT AND TEST APPLICATOR RESULTS ARE WITHIN TOLERANCE SPECIFICATIONS.