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

Model Number 2095

Device Problem Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2017

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• 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
• MDR Report Key: 6950909
• MDR Text Key: 90467265
• Report Number: 3003637274-2017-00062
• Device Sequence Number: 1
• Product Code: NTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Dental Assistant
• Type of Report: Initial
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: No
• 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: 09/25/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2014
• 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