MAUDE Adverse Event Report: KAVO DENTAL GMBH DIAGNODENT CLASSIC 2095; CARIES DETECTOR

Model Number 2095

Device Problems Fire (1245); Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2016

Event Type  malfunction  

Manufacturer Narrative

The analysis of the chargeable battery pack showed that the housing was cracked and taped together again.Also a small grafter of the housing was missing.The only explanation for this condition is that the battery pack has been dropped (which caused the crack) and put together again on the users site.Separating the 2 housing parts showed that an isolating foil was displaced.Therefore a conductor which is normally completely isolated and runs across several single cells had now contact to this cells which caused a direct short-circuit.In consequence the conductor was overloaded at this points, got hot and started to melt.This was enough heat that the housing was also melting.Root cause for the dislocation of the isolation foil was, that the person who put the 2 housing parts back together after the drop pushed the isolation foil by mistake deeper into the housing.By closing and taping the 2 housings the isolation foil has been pressed deeper and deeper inside the battery pack and the conductor has been pressed on the contacts of the single battery cells.The user instruction contains a clear note which states that the battery pack: * must not be modified or disassembled * must not be dropped or get shocks.

Event Description

Described is that the chargeable battery pack caught fire after the dental assistant removed it from the diagnodent in order to charge it.She threw it in the snow.Nobody was injured.There was no patient involved hence there are no data entered.

• Brand Name: DIAGNODENT CLASSIC 2095
• Type of Device: CARIES DETECTOR
• Manufacturer (Section D): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, bw 88400 ; GM 88400
• Manufacturer (Section G): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, bw 88400 ; GM 88400
• Manufacturer Contact: klaus reisenauer ; bismarckring 39; biberach / riss, bw 88400 ; GM 88400 ; 735156
• MDR Report Key: 5446616
• MDR Text Key: 39127733
• Report Number: 3003637274-2016-00010
• Device Sequence Number: 0
• Product Code: NTK
• Reporter Country Code: US
• PMA/PMN Number: K983658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dental Assistant
• Type of Report: Initial
• Report Date: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Dental Assistant
• Device Model Number: 2095
• Device Catalogue Number: 0.574.0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1