MAUDE Adverse Event Report: AGFA HEALTHCARE N.V. DX-D600 - DXD IMAGING PACKAGE; DX-D 600 SYSTEM

Device Problem Self-Activation or Keying (1557)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/21/2018

Event Type  malfunction  

Event Description

A customer in the (b)(6) reported to (b)(4) when using their dx-d 600 system they experienced unexpected movement.After upgrade to otc software to 13.2 or 14.5, when the auto center button is pressed the system moves continuously until end position is reached, it cannot be stopped by releasing the button, as it normally should.This has only been seen at the time of the upgrade and has not been reported by the customer when the system is in clinical use.The affected system has been downgraded to the previous version and is working as intended with this software downgrade.Investigation is underway and a supplemental report will be provided.There has been no reported harm to patient or user during these events.

Event Description

This supplement report #1 is being submitted to provide the root cause and actions taken.

Manufacturer Narrative

The root cause has been determined that when introducing the remote-control a modification was implemented in longitudinal/transversal power control pcb to monitor the signals generated in this remote-control.Boards versions before b have this line open, that could generate the described symptom.From revision b this specific channel line in the board is being used to monitor the remote-control.December 4, 2018 agfa has implemented a correction for this issue.All affected consignees received an urgent field safety notification for this issue december 4, 2018.Mandatory service bulletin id: 66744259 (sb no.141) was published december 13, 2018.Agfa or its representative will visit each affected site and install the latest revision of the hardware board, which will prevent a movement without user interaction.Any additional reporting for this correction activity will be reported to fda via 21 cfr 806 reporting via agfa id - (b)(4) (9616389-12-04-2018-004-c).The fda reference number is recall event id (b)(4).There has been no reported patient harm for this event.

• Brand Name: DX-D600 - DXD IMAGING PACKAGE
• Type of Device: DX-D 600 SYSTEM
• Manufacturer (Section D): AGFA HEALTHCARE N.V.; septestraat 27; mortsel, B2640 ; BE B2640
• MDR Report Key: 7740944
• MDR Text Key: 115920232
• Report Number: 9616389-2018-00013
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• PMA/PMN Number: K112670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1