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

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

We received a letter on may 25, 2021 from a third party representing the insurance company of a dental office that alleged a nomad pro2 handheld x-ray system was found at the source of a dental office fire.We received no notification from the dental office related to this allegation.There was no report of patient involvement, injury or death.We contacted the dental office on 6/2/2021 and was informed the fire occurred at 9:30pm on (b)(6) 2020 and the dental office was unoccupied at the time the event occurred.An official fire investigation report from the local fire marshall dated june 30, 2020 concluded the fire cause is undetermined.All equipment previously located within the affected area of the dental office, including the nomad pro2 device unit, are currently in the custody of a third party, whereby the investigation is ongoing.The third party representing the insurance company is in the process of scheduling a joint lab inspection for all parties involved where destructive testing will be performed.At the conclusion of the investigation, a follow-up mdr will be submitted with the results of our evaluation, as well as other available manufacturer data relative to the nomad pro 2 device.

Event Description

A third party representing the insurance company of a dental office alleged that a nomad pro2 unit was found at the source of a dental office fire.No injury or death.No impact to patient care.

• 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 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
• MDR Report Key: 12027860
• MDR Text Key: 264545101
• Report Number: 2530069-2021-00002
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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