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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

Visual evaluation shows the condition of the unit received from 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.Investigation of the unit revealed that the thermal event occurred when electrolytic gas swelled in one of the two battery cells in the handset, causing the cell to burst.The subsequent gas discharge caused a thermal event to occur leading to damage to the handset.Visual inspection results of the charging cradle confirms the charging cradle was not the source of the thermal event.While it is not possible to ascertain the exact chain of events that led to the thermal event, evidence and prior investigations into events of this nature, suggests that gas build-up in the battery cell(s) was released causing a thermal event.The location of the thermal event within the handset precluded determination of manufacture date of the battery handle assembly.The date of manufacture for the handset assembly was confirmed from the device history record.This completes the investigation.This device and associated malfunction was subject to a class 2 recall ((b)(4)) and was initiated by the original manufacturer, kavo dental technologies, llc dba aribex located in (b)(4), on (b)(6) 20.16 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 did not responded back to aribex following multiple attempts, in response to the recall.This particular device was returned to dental imaging technologies corporation on january 28, 2021 for complaint investigation and as a result the handset was replaced.Note: nomad device manufacturing has been moved from kavo dental technologies, llc dba aribex in (b)(4) to dental imaging technologies corporation in (b)(4) in (b)(6) 2020.

Event Description

Unit caught fire - no injury or death.No impact to patient care.

• 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 19440
• Manufacturer (Section G): DENTAL IMAGING TECHNOLOGIES CORPORATION; 1910 north penn road; hatfield PA 19440
• Manufacturer Contact: al myers ; 1910 north penn road; hatfield, PA 19440 ; 2679540270
• MDR Report Key: 11317416
• MDR Text Key: 232816333
• Report Number: 2530069-2021-00001
• 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 faci
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• 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: 01/28/2021
• Date Manufacturer Received: 01/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2012
• 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