LED HEADLIGHT W/ BATTERIES AND AC/DC POWER SUPPLY - US
Received Oct 16, 2014
Report 1222895-2014-00029 · MDR key 4184014
Device
Product problems
- Thermal Decomposition of Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED "NO LIGHT". BURNED PRINTED CIRCUIT BOARD DISCOVERED DURING DEALER INSPECTION. NO PATIENT OR USER ISSUES REPORTED.
Additional Manufacturer Narrative
ON (B)(6) 2014, INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - THE CUSTOMER'S COMPLAINT WAS CONFIRMED. PER THE REPAIR EVALUATION, THE CONTROL BOARD WAS FAULTY AND WAS REPLACED. DEVICE HISTORY EVALUATION - THE PRODUCT'S SERVICE HISTORY WAS REVIEWED. THERE HAVE BEEN NO PREVIOUS ACTIVITIES PERFORMED. CONCLUSION: UNABLE TO DETERMINE ROOT CAUSE FOR THIS FAILURE.