MalfunctionIPF
CHATTANOOGA VECTRA NEO
Received Nov 21, 2019 · Event occurred Oct 30, 2019
Report 9616086-2019-00082 · MDR key 9354148
Product problems
- Energy Output Problem
- Energy Output Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
NO DEVICE WAS RETURNED FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT EVALUATION.
Description of Event or Problem
IT WAS REPORTED THAT INTENSITY ON ELECTROSTIMULATION JUMPS UP WITHOUT WARNING DURING TREATMENT. THERE WAS REPORTEDLY NO PATIENT HARM.