MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-19 for DIAGNODENT CLASSIC 2095 0.574.0500 manufactured by Kavo Dental Gmbh.
[39127733]
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.
Patient Sequence No: 1, Text Type: N, H10
[39127734]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003637274-2016-00010 |
| MDR Report Key | 5446616 |
| Date Received | 2016-02-19 |
| Date of Report | 2016-01-21 |
| Date of Event | 2016-01-21 |
| Date Mfgr Received | 2016-02-11 |
| Device Manufacturer Date | 2008-01-29 |
| Date Added to Maude | 2016-02-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KLAUS REISENAUER |
| Manufacturer Street | BISMARCKRING 39 |
| Manufacturer City | BIBERACH / RISS, BW 88400 |
| Manufacturer Country | GM |
| Manufacturer Postal | 88400 |
| Manufacturer Phone | 735156 |
| Manufacturer G1 | KAVO DENTAL GMBH |
| Manufacturer Street | BISMARCKRING 39 |
| Manufacturer City | BIBERACH / RISS, BW 88400 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 88400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DIAGNODENT CLASSIC 2095 |
| Generic Name | CARIES DETECTOR |
| Product Code | NTK |
| Date Received | 2016-02-19 |
| Returned To Mfg | 2016-02-11 |
| Model Number | 2095 |
| Catalog Number | 0.574.0500 |
| Operator | DENTAL ASSISTANT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | KAVO DENTAL GMBH |
| Manufacturer Address | BISMARCKRING 39 BIBERACH / RISS, BW 88400 GM 88400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-19 |