DIAGNODENT CLASSIC 2095
Received Oct 16, 2017 · Event occurred Sep 25, 2017
Report 3003637274-2017-00062 · MDR key 6950909
Device
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
THE EQUIPMENT (DIAGNODENT CARIES DETECTOR) WAS SENT FROM THE DENTAL OFFICE TO THE REPAIR SHOP OF KAVO USA FOR A CHECK/ REPAIR AS THE PRODUCT DID NOT SHOW THE CORRECT VALUES ANYMORE. WHEN THE ASSOCIATE OF THE REPAIR DEPARTMENT OPENED THE PARCEL HE RECOGNIZED THAT THE BATTERY PACK (ACCESSORY OF THE DIAGNODENT) HAD OVERHEATED DURING THE SHIPMENT FROM DENTAL OFFICE TO THE REPAIR SHOP OF KAVO USA. A CLOSER LOOK TO THE BATTERY PACK SHOWED THAT THE TWO PARTS OF THE CASING HAVE BEEN SEPARATED. AS THEY ARE ULTRASONIC - WELDED THIS COULD ONLY HAPPEN IF IT RECEIVES A STRONG HIT FROM OUTSIDE. THIS COULD EITHER BE THE RESULT OF A DROP AT CUSTOMER'S SITE OR A STRONG HIT DURING THE TRANSPORT. AS THE CARIES DETECTOR HAD NO DAMAGES IT IS UNLIKELY THAT THE EXTERNAL FORCE WAS RECEIVED DURING THE SHIPMENT. HENCE THE STRONG SUSPICION IS THAT THE BATTERY PACK WAS DROPPED AT CUSTOMER'S SITE. A STRONG EXTERNAL FORCE (IN THIS CASE WITH DEFORMATION / CRACKING OF THE CASING) COULD RESULT IN DAMAGES INSIDE THE BATTERY PACK. IT COULD HAPPEN THAT SINGLE CELLS GET DAMAGED IN A WAY THAT THEY OVERHEAT, BUT IT COULD ALSO HAPPEN THAT THE CONNECTION AND INSULATION BETWEEN THE SINGLE CELLS GET DAMAGED WHICH COULD ALSO CAUSE OVERHEATING. AS THE BATTERY PACK IS BASED ON NIMH- NOT LI- TECHNOLOGY THE OVERHEATING IS ALREADY WORST CASE SCENARIO. THIS KIND OF BATTERIES ARE NOT STRONG ENOUGH TO CAUSE STRONGER REACTIONS.
Description of Event or Problem
IT IS DESCRIBED THAT WHEN THE PRODUCT WAS UNPACKED AT THE REPAIR DEPARTMENT OF KAVO USA IT WAS DETECTED THAT THE RECHARGEABLE BATTERY PACK HAD OVERHEATED DURING THE TRANSPORT. THE CASING OF THE BATTERY PACK WAS CRACKED AND AT ONE POSITION THE HOUSING WAS MELTED. NOBODY WAS INJURED, NO MEDICAL CARE NECESSARY.