MalfunctionIPF
CHATTANOOGA VECTRA NEO
Received Oct 23, 2019 · Event occurred Sep 28, 2019
Report 9616086-2019-00076 · MDR key 9225565
Product problems
- Power Conditioning Problem
- Power Conditioning 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 UPON INCREASING THE INTENSITY, WHILE SET ON STIMULATION, THE UNIT RAISES ALL THE WAY TO ITS MAXIMUM. THE UNIT WAS QUICKLY TURNED OFF AND THERE WAS REPORTEDLY NO PATIENT HARM. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.