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

Model Number DX-D600

Device Problem Unintended Movement (3026)

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

Event Date 09/20/2016

Event Type  malfunction  

Event Description

We are reporting this mdr reportable event on october 11, 2016.On (b)(6) 2016, a customer reported an event of unexpected movement with one dx-d600 x-ray unit.While the customer was using the unit on (b)(6) 2016, the unit wall stand failed to engage the brakes and rose quickly to the top.Investigation is underway to determine root cause and any corrective action as needed.A supplemental report will be provided.There has been no reported harm to patient or user during this event.

Manufacturer Narrative

The root cause was identified by february 14, 2017 during the investigation by agfa and the supplier.A defective wall stand handle caused a malfunction in the ws push button, keeping the switch activated after release of the button.Agfa field service replaced the wall stand handle and the omni button.This correction was confirmed and the system is now working as intended.There have been no reports of harm to users or patients during these events.

Event Description

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

• Brand Name: DX-D600 -DXD IMAGING PACKAGE
• Type of Device: DX-D 600 SYSTEM
• Manufacturer (Section D): AGFA HEALTHCARE N.V.; septestraat 27; mortsel, belgium B 264 0; BE B 2640
• Manufacturer (Section G): AGFA HEALTHCARE N.V.; septestraat 27; mortsel, belgium B 264 0; BE B 2640
• Manufacturer Contact: cassandra mcgowan ; 10 south academy street; greenville, SC 29601 ; 8644211984
• MDR Report Key: 6018742
• MDR Text Key: 57563881
• Report Number: 9616389-2016-00008
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K112670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2017

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
• Device Operator: Health Professional
• Device Model Number: DX-D600
• Device Catalogue Number: 5430/140
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/21/2016
• Initial Date FDA Received: 10/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1