MalfunctionIPF
CHATTANOOGA VECTRA NEO
Received Dec 30, 2019 · Event occurred Dec 10, 2019
Report 9616086-2019-00089 · MDR key 9529951
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
HEALTH PROFESSIONAL: UNKNOWN. OCCUPATION: UNKNOWN. 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 THE "E-STIM MACHINE IS JUMPING WITH THE CURRENT BEING DELIVERED. CUSTOMER DOES NOT GET ANY ERROR CODE AND UNIT DOES NOT STOP TREATMENT. THEREFORE, SAFETY FEATURE FAIL TO ACTIVATE." THERE WAS NO REPORTED PATIENT HARM.