MAUDE Adverse Event Report: DENTAL IMAGING TECHNOLOGIES CORPORATION NOMAD PRO2; EXTRAORAL SOURCE X-RAY SYSTEM

Model Number 0.850.0021

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2020

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 started at the lower battery cell and migrated upward in the handset.The extent of the thermal event which resulted in the information to be illegible and unreadable, the plastic of the housing melting and losing its form and integrity, and observable thermal damage to the battery interface board resulting in difficulty of removing of the battery interface board for further investigation.The plastic of the handset / housing has melted away from the area containing the battery pack.Any further investigation in this area cannot be performed due to the damage.This completes the investigation.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 (b)(4), 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 november 3, 2016 and acknowledged the recall but did not want to replace this handset.This particular device was returned to dental imaging technologies corporation on december 14, 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.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 march 2020.

Event Description

Handset caught on fire.No impact to patient care.No injury reported.

• Brand Name: NOMAD PRO2
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): DENTAL IMAGING TECHNOLOGIES CORPORATION; 1910 north penn road; hatfield, pa
• Manufacturer (Section G): DENTAL IMAGING TECHNOLOGIES CORPORATION; 1910 north penn road; hatfield, pa
• Manufacturer Contact: al myers ; 1910 north penn road; hatfield, pa
• MDR Report Key: 11057201
• MDR Text Key: 242900248
• Report Number: 2530069-2020-00002
• 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: Dentist
• Type of Report: Initial
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0.850.0021
• Device Catalogue Number: FP 0150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2013
• 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