CHATTANOOGA
Received Sep 30, 2015 · Event occurred Sep 21, 2015
Report 9616086-2015-00026 · MDR key 5114211
Product problems
- Self-Activation or Keying
- Failure to Shut Off
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pain
- Electric Shock
Narrative
Additional Manufacturer Narrative
DEVICE NOT RETURNED.
Description of Event or Problem
COMPLAINT RECEIVED THAT ALLEGES "THEY WERE DOING AN E-STIM TREATMENT AND THE UNIT'S INTENSITY CONTINUED TO INCREASE WITHOUT ANYONE TURNING IT UP. THIS CAUSED PAIN IN THE RESIDENT AND WHEN THEY TRIED TO TURN IT OFF, THEY COULDN'T AND HAD TO PULL OFF THE ELECTRODES WHICH THEN SHOCKED THE THERAPIST. THE RESIDENT HAS EXPERIENCE CONSTANT PAIN THROUGHOUT THE WEEKEND WHERE THE PADS WERE ATTACHED. THE PATIENT IS GOING TO SEE THEIR PRIMARY DR. FOR THESE INJURIES". QUESTIONNAIRE WAS NOT RECEIVED FROM CLINICIAN AND/OR PATIENT. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION. NO INDICATION EVENT CAUSED OR CONTRIBUTED TO PERMANENT IMPAIRMENT OR DEATH. NO INDICATION DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.
Additional Manufacturer Narrative
PRODUCT WAS RETURNED FOR REVIEW. THE PRODUCT MET SPECIFICATIONS AND DID NOT MALFUNCTION. THE UNIT AND APPLICATOR PASSED ALL FUNCTIONAL AND COSMETIC TESTING. NO ACCESSORIES WERE INCLUDED FOR EVALUATION (LEADWIRES, ELECTRODES) . ADDITIONAL INFORMATION DOES NOT CHANGE ORIGINAL NOT REPORTABLE DECISION.