DIAGNODENT CLASSIC

Description of Event or Problem

ACCORDING TO INFORMATION FROM DENTAL OFFICE THE BATTERY PACK WAS GETTING HOT WHILE IN USE ON THE DIAGNODENT CARIES DETECTOR. DOCTOR REMOVED THE BATTERY PACK FROM THE DIAGNODENT, THEN IT STARTED TO SPARK AND CAUGHT FIRE. NOBODY WAS INJURED.

Additional Manufacturer Narrative

THE EVALUATION PERFORMED BY AN INDEPENDENT INSTITUTE SHOWED THAT THE ORIGIN OF THE HEAT MUST BE FROM A SINGLE BATTERY CELL WITHIN THE BATTERY PACK WHICH GOT TOO HOT. ACCORDING TO THE INSTITUTE IT IS NOT POSSIBLE TO IDENTIFY THE ROOT CAUSE FOR THE OVERHEATING OF A SINGLE CELL AS THERE ARE VARIOUS POSSIBILITIES LIKE: FAILURE IN THE CELL DUE TO A HIT, E.G. FROM DROPPING, INACCURATE WELDING POINT ON ONE POLE AND THEREFORE A HIGHER CONTACT RESISTANCE, EXHAUSTIVE DISCHARGE OF A SINGLE CELL AND FURTHER POSSIBILITIES. BESIDE THE ISSUE WE REPORTED WITH MDR 3003637274-2015-00005 (IN THIS CASE IT WAS A DEFECT DUE TO DROPPING OF THE BATTERY PACK) WE ARE NOT AWARE OF FURTHER BURNING ISSUES. AS THERE ARE MORE THAN (B)(4) BATTERY PACKS DELIVERED AND ONLY (B)(4) INCIDENTS ARE KNOWN IT IS VERY LIKELY THAT ALSO THIS SECOND INCIDENT IS CAUSED BY A HANDLING FAILURE. THEREFORE THE CONCLUSION CODE IS SELECTED CORRESPONDINGLY. THE USER INSTRUCTION CONTAINS A NOTE THAT RECHARGEABLE BATTERIES MUST NOT BE DROPPED OR RECEIVED HITS FROM OTHER SOURCES.

Additional Manufacturer Narrative

AS IT IS NOT POSSIBLE TO SEND THE CHARGEABLE BATTERY PACK BACK TO THE VENDOR IN (B)(4) FOR EVALUATION WE CONSULTED AN INDEPENDENT INSTITUTE TO ANALYZE SOME CHARGEABLE BATTERY PACK OUT OF THE SAME PRODUCTION PERIOD TO VERIFY THAT THEY MEET SPECIFICATION. THE PROCESS IS STARTED AND TAKES AT LEAST ADDITIONAL 3 WEEKS. AS SOON AS WE HAVE A RESULT WE WILL ISSUE A FOLLOW UP REPORT.