CHATTANOOGA APPLICATOR SINGLE 850NM 100MW
Received Mar 9, 2020 · Event occurred Feb 24, 2020
Report 3012446970-2020-00010 · MDR key 9805355
Product problems
- Power Problem
- Power Problem
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 "POWER OUTPUT IS TOO HIGH, GETTING 150MW (MEGAWATTS) ON A 100MW APPLICATOR". THERE WAS NO REPORTED PATIENT HARM. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.
Additional Manufacturer Narrative
H3, H6: UPDATED PER EVALUATION REPORT OF RETURNED DEVICE. OUTPUT POWER WAS DECREASED. APPLICATOR WAS CALIBRATED WITH A BURN-IN PROCEDURE. OUTPUT POWER WAS VERIFIED TO MEET DEVICE SPECIFICATIONS. THE DEVICE WAS SUCCESSFULLY CALIBRATED AND PASSED FULL-FUNCTIONAL TESTS AS WELL AS BURN-IN.