MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-16 for DIAGNODENT CLASSIC 2095 0.574.0500 manufactured by Kavo Dental Gmbh.
[90467265]
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.
Patient Sequence No: 1, Text Type: N, H10
[90467266]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003637274-2017-00062 |
| MDR Report Key | 6950909 |
| Date Received | 2017-10-16 |
| Date of Report | 2017-10-16 |
| Date of Event | 2017-09-25 |
| Date Mfgr Received | 2017-09-25 |
| Device Manufacturer Date | 2014-05-20 |
| Date Added to Maude | 2017-10-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 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 | 2017-10-16 |
| Returned To Mfg | 2017-09-25 |
| Model Number | 2095 |
| Catalog Number | 0.574.0500 |
| Operator | DENTAL ASSISTANT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| 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 | 2017-10-16 |