MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2015-07-03 for DIAGNODENT CLASSIC KAVO DIAGNODENT 2095 05740500 manufactured by Kavo Dental Gmbh.
[6829909]
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.
Patient Sequence No: 1, Text Type: D, B5
[14252261]
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.
Patient Sequence No: 1, Text Type: N, H10
[30868077]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003637274-2015-00013 |
| MDR Report Key | 4889794 |
| Report Source | 06,USER FACILITY |
| Date Received | 2015-07-03 |
| Date of Report | 2015-06-05 |
| Date of Event | 2015-06-04 |
| Date Mfgr Received | 2015-06-05 |
| Device Manufacturer Date | 2014-05-20 |
| Date Added to Maude | 2015-07-30 |
| 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 | DENTIST |
| 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 | 3 |
| Brand Name | DIAGNODENT CLASSIC |
| Generic Name | CARIES DETECTOR |
| Product Code | NBL |
| Date Received | 2015-07-03 |
| Model Number | KAVO DIAGNODENT 2095 |
| Catalog Number | 05740500 |
| Operator | DENTAL ASSISTANT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2015-07-03 |