MalfunctionGZI
CHATTANOOGA VECTRA GENISYS 2CH COMBO PKG US STD, 5CM APPL
Received Dec 23, 2019 · Event occurred Apr 11, 2019
Report 9616086-2019-00085 · MDR key 9510522
Device
Product problems
- Intermittent Energy Output
- Intermittent Energy Output
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ONE VECTRA GEN 2C COMBO UNIT WAS RETURNED FOR EVALUATION. THE UNIT PASSED FUNCTIONAL AND SAFETY TESTING. ALL WAVEFORMS TESTED WITHIN TOLERANCE. CUSTOMER DID NOT SEND IN ANY LEADWIRES OR ELECTRODES FOR EVALUATION.
Description of Event or Problem
IT WAS REPORTED THAT THE "INTENSITY INTERMITTENTLY SURGES" DURING TREATMENT. THERE WAS NO REPORTED PATIENT HARM.