CHATTANOOGA
Received Feb 12, 2025 · Event occurred Jan 15, 2025
Report 9616086-2025-00011 · MDR key 21370553
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
THE CLINICIAN REPORTED A SMALL BURN ON THE PATIENT AFTER WHICH THIS UNIT WAS PROMPTLY REMOVED FROM SERVICE. DISCOVERED THE DEVICE HAD DEFECTIVE INTENSITY ENCODER. CRACKED LEAD-WIRES INLET. BROKEN CONTROL BOARD TO STIM BOARD RIBBON CABLE CONNECTOR. DEFECTIVE LCD SCREEN, DARK, VERTICAL LINE. 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 COULD WAS NOT ESTABLISHED, POOR CONDITION OF THE ELECTRODES THE CLIENT WAS USING COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE.
Description of Event or Problem
THE CLINICIAN REPORTED A SMALL BURN ON THE PATIENT AFTER WHICH THIS UNIT WAS PROMPTLY REMOVED FROM SERVICE.