MAUDE Adverse Event Report: AGFA N.V. AGFA DX-D 100

Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united kingdom reported unintended movement of a dx-d 100 system.The user stated the system was being moved when it accelerated into a wall and began beeping.There were no patients involved.The local agfa field service engineer responded to investigate the issue and completed several system checks.During the investigation, agfa service replaced the dmc board and the system worked as intended.There have been no additional reported events.As part of the device investigation by agfa and the supplier, the removed board was tested and worked as intended.The root cause for the reported event is unknown.There has been no reported harm to patient or users for this event.
Event or Problem Description
This supplement report #1 is being submitted to correctly identify this report as part of the vmsr (voluntary malfunction summary reporting) program.The below event description (b5) has been updated to include the number of events.This report summarizes 1 malfunction event.A customer in the united kingdom reported unintended movement of a dx-d 100 system.The user stated the system was being moved when it accelerated into a wall and began beeping.There were no patients involved.The local agfa field service engineer responded to investigate the issue and completed several system checks.During the investigation, agfa service replaced the dmc board and the system worked as intended.There have been no additional reported events.As part of the device investigation by agfa and the supplier, the removed board was tested and worked as intended.The root cause for the reported event is unknown.There has been no reported harm to patient or users for this event.Also section report: exemption/variance number is updated to: vmsr.

• Brand Name: AGFA DX-D 100
• Common Device Name: DX-D 100
• Manufacturer (Section D): AGFA N.V.; septestraat 27; mortsel B2640 ; BE B2640
• Manufacturer (Section G): AGFA N.V.; septestraat 27; mortsel B2640 ; BE B2640
• Manufacturer Contact: cassandra mcgowan ; 580 gotham parkway; carlstadt, NJ 07072 ; 8644211984
• MDR Report Key: 21880089
• Report Number: 3001556265-2025-00001
• Device Sequence Number: 8742592
• Product Code: IZL
• UDI-Device Identifier: 05414904094440
• UDI-Public: 05414904094440
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K103597
• Exemption Number: VMSR
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown