DIAGNODENT CLASSIC KAVO DIAGNODENT 2095 05740500

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number3003637274-2015-00013
MDR Report Key4889794
Report Source06,USER FACILITY
Date Received2015-07-03
Date of Report2015-06-05
Date of Event2015-06-04
Date Mfgr Received2015-06-05
Device Manufacturer Date2014-05-20
Date Added to Maude2015-07-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. KLAUS REISENAUER
Manufacturer StreetBISMARCKRING 39
Manufacturer CityBIBERACH / RISS, BW 88400
Manufacturer CountryGM
Manufacturer Postal88400
Manufacturer Phone735156
Manufacturer G1KAVO DENTAL GMBH
Manufacturer StreetBISMARCKRING 39
Manufacturer CityBIBERACH / RISS, BW 88400
Manufacturer CountryGM
Manufacturer Postal Code88400
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDIAGNODENT CLASSIC
Generic NameCARIES DETECTOR
Product CodeNBL
Date Received2015-07-03
Model NumberKAVO DIAGNODENT 2095
Catalog Number05740500
OperatorDENTAL ASSISTANT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerKAVO DENTAL GMBH
Manufacturer AddressBISMARCKRING 39 BIBERACH / RISS, BW 88400 GM 88400


Patients

Patient NumberTreatmentOutcomeDate
10 2015-07-03

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