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 Headache (1880)

Event Date 08/04/2022

Event Type  malfunction  

Manufacturer Narrative

Visual evaluation shows the condition of the unit while in the field.Upon visual investigation of the unit, it was concluded that a thermal event did take place resulting in the appearance of the affected unit.This particular device was not returned to dental imaging technologies corporation at time of this report.However, a follow-up report will be submitted, if returned and investigation completed.Note: 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.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.Aribex notified all customers of the recall while the recall was open.This particular customer received replacement handsets on 8/9/2016 under the recall.Note: nomad device manufacturing has been moved from kavo dental technologies, llc dba aribex in charlotte, nc to dental imaging technologies corporation in quakertown, pa in july 2022.

Event Description

Per (b)(4): unit caught fire - customer reported a unit was stored in a cabinet on its' charger and not in use when they smelled smoke.Upon locating the source of the smell, an associate opened the storage cabinet and observed the unit was on fire.Two (2) staff members reported having a headache from the smoke.

Manufacturer Narrative

Upon visual inspection, a thermal event did occur.While on the charging cradle, an aribex handset may have caused the thermal event which damaged both the handset and cradle.It is not possible to determine the exact cause 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 pcb.This battery has passed its established end of life.The rechargeable batteries last about 2-3 years or 300 charge/discharge cycles, if they have been used properly.In this case, the battery has been in use for at least 6 years.Overcharging and over-discharging of the batteries can result in the cells swelling and allowing egress of electrolyte which may have caused or contributed toward the removal of the solder mask material on the pcb, contributing to the thermal event.However, it is not feasible to determine the correlation of the thermal event and the potential electrolyte leakage.The nomad pro 2, with a newly designed battery and handset, was 510(k) cleared on november 16, 2017.The battery and handsets subject of this investigation are no longer distributed with nomad pro 2.

Manufacturer Narrative

The operator manual section 5 (handset replacement and care) instructs the user of steps to maintain the handset.The section "important handset care notes" indicates "when the charging cradle senses a bad handset battery, the indicator lights will illuminate red rather than green.In this case, the batteries are inoperable and must be serviced.".Upon further follow-up with the end user on (b)(6) 2022, the end user indicated the red indicator light previously illuminated however they continued to use the handset with battery.This concludes the investigation.

• Brand Name: NOMAD PRO
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): DENTAL IMAGING TECHNOLOGIES CORPORATION; 450 commerce drive; quakertown PA 18951
• Manufacturer (Section G): DENTAL IMAGING TECHNOLOGIES CORPORATION; 450 commerce drive; quakertown PA 18951
• Manufacturer Contact: al myers ; 450 commerce drive; quakertown, PA 18951 ; 8888323947
• MDR Report Key: 15493728
• MDR Text Key: 300668816
• Report Number: 3021551-2022-00001
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081664
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2012
• 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