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

Model Number T-100

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2022

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 288015096
• Report Number: 1000113729-2022-00001
• Device Sequence Number: 1
• Product Code: EHD
• UDI-Device Identifier: 00858475006153
• UDI-Public: 010085847500615311181004
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 02/15/2022
• Distributor Facility Aware Date: 01/11/2022
• Device Age: 40 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1