MalfunctionIPF
CHATTANOOGA LEGEND XT 4CH STIM PKG US STD
Received Feb 3, 2020 · Event occurred Jan 15, 2020
Report 9616086-2020-00005 · MDR key 9659576
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 "WHEN INCREASING OR DECREASING INTENSITY KNOB, THE INTENSITY WILL FLUCTUATE INCREASING AND DECREASING THE INTENSITY. INTENSITY IS NOT STABLE WHEN NOT MOVING THE KNOB." THIS REPORTEDLY OCCURRED DURING TREATMENT, BUT NO PATIENT HARM WAS REPORTED.