MalfunctionILY
CHATTANOOGA APPLICATOR 9CLS 5X200MW 1040MW
Received Mar 9, 2020 · Event occurred Feb 24, 2020
Report 3012446970-2020-00008 · MDR key 9805356
Product problems
- Overheating of Device
- Overheating of Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
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 UNIT WAS GETTING TOO HOT". THERE WAS NO REPORTED PATIENT HARM.
Additional Manufacturer Narrative
H3, H6: DEVICE WAS RETURNED FOR EVALUATION. REPLACED LASER CABLE AND IP BOARD. THE DEVICE WAS CALIBRATED AD PASSED FULL FUNCTIONAL TESTS AND BURN-IN SUCCESSFULLY.