MAUDE Adverse Event Report: DEL MEDICAL INC FMT 18 MANUAL SYSTEM; DIGITAL RADIOGRAPHIC SYSTEM

Medical Device Problem Code	Unexpected/Unintended Radiation Output (4028)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On may 1, 2026, del medical technical support (ts) duplicated the problem by integrating the vieworks software to a cm series generator (s/n (b)(6)).An aec feedback error was displayed on the vieworks screen.It was found that it was possible to prep and make a second exposure without pressing reset to clear the error.Ts concluded that the issue was directly related to the vieworks software being fully integrated into generator.Ts provided the event logs to the software provider, vieworks america, for evaluation.On may 11, 2026, the fse replaced turned off generator integration for vieworks.The unit was tested and it was confirmed that it was able to block exposure while an error was displayed.The fse confirmed that the system was operational.On may 20, 2026, vieworks developed a software patch to place the generator in a communication fault when error occurs.The generator would no longer receive a reset signal while an error is being displayed, preventing exposure.
Event or Problem Description
On (b)(6) 2026, the physicist failed the generator during installation for allowing exposure without the requirement to reset a previous aec back up time error.The unit was using a cm series generator integrated with vivix dr.There was no injury reported.

• Brand Name: FMT 18 MANUAL SYSTEM
• Common Device Name: DIGITAL RADIOGRAPHIC SYSTEM
• Manufacturer (Section D): DEL MEDICAL INC; 241 covington drive; bloomingdale IL 60108
• Manufacturer (Section G): DEL MEDICAL INC; 241 covington drive; bloomingdale IL 60108
• Manufacturer Contact: george bell ; 241 covington drive; bloomingdale, IL 60108 ; 8008006006
• MDR Report Key: 25339231
• Report Number: 0001418964-2026-00005
• Device Sequence Number: 10002469
• Product Code: KPR
• UDI-Device Identifier: 00858340006189
• UDI-Public: 00858340006189
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown