MAUDE Adverse Event Report: DENTERPRISE INTL INC. MOBILEX T-100; PORTABLE HANDHELD X-RAY GENERATOR

Model Number	T-100
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Operator reported battery fire in mobilex handheld portable x-ray unit sn (b)(4).Unit was idle on counter at time fire was observed.No injuries occurred.

• Brand Name: MOBILEX T-100
• Common Device Name: PORTABLE HANDHELD X-RAY GENERATOR
• Manufacturer (Section D): DENTERPRISE INTL INC.; 100 e. granada blvd; suite 219; ormond beach FL 32176
• MDR Report Key: 13538447
• Report Number: 1000113729-2022-00001
• Device Sequence Number: 4730464
• Product Code: EHD
• UDI-Device Identifier: 00858475006153
• UDI-Public: 010085847500615311181004
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/15/2022
• Report Date (Section F): 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: T-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/11/2022
• Device Age: 40 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/15/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/15/2022