MAUDE Adverse Event Report: AGFA N.V. AGFA DR 400

Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in germany reported the collimator fell off a dr 400 system.The customer was turning the tube from the table to the wallstand and the plastic flange broke and the collimator fell from the system.The local agfa field service engineer was at the customer site completing an unrelated service and was able to review the broken flange.The local service engineer replaced the broken flange and reattached the system colimator.There were no reported injuries to user or patients.The system is now working as intended and there are no future actions related to this event.
Additional Manufacturer Narrative
This supplement report #1 is being submitted to correctly identify this report as part of the vmsr (voluntary malfunction summary reporting) program.Section report is updated to include "vmsr".Section (b5) has been updated to include the number of events.
Event or Problem Description
This section (b5) has been updated to include the number of events.This report summarizes 1 malfunction event.

• Brand Name: AGFA DR 400
• Common Device Name: DR 400
• 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: 21069400
• Report Number: 3001556265-2024-00003
• Device Sequence Number: 3277660
• Product Code: MQB
• UDI-Device Identifier: 05414904176252
• UDI-Public: 05414904176252
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141192
• 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): 05/27/2025

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: 11/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 05/27/2025
• 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