MAUDE Adverse Event Report: AGFA N.V. DX-D 300

Device Problems Unintended System Motion (1430); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2020

Event Type  malfunction  

Event Description

A customer in (b)(6) reported to agfa an event related to the dxd 300 system.The customer reported during preparation to complete a lower extremity exposure, the user pressed the height-up button on the remote control in order to move the u-arm upwards but it moved downwards instead.The u-arm came to a sudden stop and the collimator pressed against the patient's leg but not with enough pressure to cause physical harm.Investigation is underway and a supplemental report will be provided.There has been no reported patient harm for this event.

Manufacturer Narrative

Agfa service responded and checked the dx- d 300 system including the fuses and cables.There were no issues found with the system hardware.Agfa service believed the issue may be with the gear motor box which moves the carriage up and down.The gear motor box was replaced.The dx-d 300 system is now working as intended and no additional events have been reported.As part of the device investigation, the dx-d 300 system connections were checked, the log files reviewed, and the replaced parts were returned to the supplier.When tested in another system, the returned motor functioned as expected.Based on the log files that were reviewed, there was no logging of the vertical movement as described by the customer.With all the information reviewed, the investigation did not confirm a root cause for this event.Agfa service recommended to the customer to only use the emergency button in real emergency cases and not to use the emergency button as a standard way to stop the system.There are no additional corrective actions for this event.There has been no reported harm to patient or users for this event.

Event Description

This supplement report #1 is being submitted to provide the root cause and actions taken.See h10 for additional information.

• Brand Name: DX-D 300
• Type of Device: DX-D 300
• Manufacturer (Section D): AGFA N.V.; septestraat 27; mortsel, B2640 ; BE B2640
• MDR Report Key: 9714362
• MDR Text Key: 191310999
• Report Number: 3001556265-2020-00002
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• PMA/PMN Number: K103050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1