MAUDE Adverse Event Report: DENTAL IMAGING TECHNOLOGIES CORPORATION NOMAD PRO; EXTRAORAL SOURCE X-RAY SYSTEM

Model Number 0.850.0009

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 04/14/2020

Event Type  malfunction  

Manufacturer Narrative

Visual evaluation shows the condition of the unit received from the field.Upon visual inspection a thermal event did occur.It is not possible to determine the exact sequence of events that led to the thermal event.Based on previous investigations with the same type of battery, a short may have occurred in the upper battery pack between the cells and printed circuit.The part and lot number of the hand held unit.Based on the serial number sequence, the battery was manufactured september 9, 2015.According to our records, the handset battery handle assy was manufacture february 9, 2016.Based on the visual inspection of the printed circuit board, thermal damage involved charring on the printed circuit board.Due to the melting of the plastic, it is difficult to remove the printed circuit board for further investigation.The plastic encasing has melted away from the area containing the battery pack.Any further investigation in this area cannot be completed due to the damage.The upper battery pack is still enclosed in the handle section of the handset.Visual evaluation of the handle section leads us to believe that the upper battery pack was not involved in the thermal event.The cell pouches of the lower battery pack were completely destroyed by thermal event, exposing and fusing two of the three the electrodes.With the absence of the cell pouch it cannot be determined if electrolyte leakage contributed to the thermal event.Based on previous investigations with the same type of battery, a electrolyte leakage could have occurred.This completes the investigation.

Event Description

Battery caught on fire on the charging cradle - no impact to patient care.No injury reported.

Manufacturer Narrative

This device and associated malfunction was subject to a class 2 recall (z-2016/2017-2016) and was initiated by the original manufacturer, kavo dental technologies, llc dba aribex located in charlotte nc, on april 1, 2016.The recall was initiated due to potential thermal events from batteries in the device handsets.The recall was terminated by fda on july 26, 2017.Aribex notified all customers of the recall while the recall was open.This particular customer responded back to aribex on (b)(6) 2016 and acknowledged the recall but did not want to replace this handset.This particular device was returned to dental imaging technologies corporation on (b)(6) 2020 for complaint investigation and as a result the handset was replaced.The battery has an expected service life of 1-2 years and the user did not follow the operators manual recommendations of service replacement of the handset batteries.This event is being reported as part of recall z-2016/2017-2016 to fulfill regulatory reporting obligations under 21 cfr part 803 and 806.No further investigations or actions are required as recall has been terminated.Note: nomad device manufacturing has been moved from kavo dental technologies, llc dba aribex in charlotte, nc to dental imaging technologies corporation in hatfield, pa in march, 2020.

• Brand Name: NOMAD PRO
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): DENTAL IMAGING TECHNOLOGIES CORPORATION; 1910 north penn road; hatfield, pa
• MDR Report Key: 10098528
• MDR Text Key: 200829219
• Report Number: 2530069-2020-00001
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• PMA/PMN Number: K081664
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0.850.0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2020
• Date Manufacturer Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1