CHATTANOOGA
Received Feb 5, 2025 · Event occurred Jan 8, 2025
Report 9616086-2025-00005 · MDR key 21317570
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Patient Device Interaction Problem
- Adverse Event Without Identified Device or Use Problem
- Patient Device Interaction Problem
Patient
NA · Unknown
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE UNIT HAS GIVEN ELECTRICAL BURNS TO PATIENTS. DEVICE WAS RETURNED AND EVALUATED, DURING THE EVALUATION IT WAS DISCOVERED THE DEVICE HAD DEFECTIVE INTENSITY ENCODER. DAMAGED KNOB. BROKEN TOP CASING. WORN-OUT ELECTRODES. REPLACED PARTS. CLEANED UP UNIT THOROUGHLY INSIDE AND OUT. CONDUCTED FULL FUNCTIONAL TEST. RECOMMENDED FOR THE CUSTOMER TO REPLACE ELECTRODES FREQUENTLY WITH GOOD QUALITY ONES. THE ROOT CAUSE OF THE SHOCKS TO THE PATIENTS WAS THE POOR CONDITION OF THE ELECTRODES THE CLIENT WAS USING.
Description of Event or Problem
IT WAS REPORTED THAT THE UNIT HAS GIVEN ELECTRICAL BURNS TO PATIENTS.