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

Model Number DX-D600

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Information (3190)

Event Date 02/22/2016

Event Type  malfunction  

Manufacturer Narrative

The description of the event was incorrect with reference to unintended movement.There was no movement involved with this event.This supplemental report #1 is being submitted to correctly provide the description of the overall event.An event of the detent dropping down of one dx-d 600 unit occurred at the site on (b)(6) 2016.The customer reported that while moving the tube, one of the hardware detents from the dx-d600 had fallen off the overhead rail.Agfa field service immediately responded to the call and successfully installed self-drilling screws to the detent rails on the system for this customer.This correction was confirmed on february 27, 2016.The system is now working as intended.Investigation is under way to determine the root cause and supplemental reporting will be provided.There has been no reported harm to patient or user during this event.

Event Description

An event of unintended movement of one dx-d600 unit occurred at the site on (b)(6) 2016.The customer reported that while moving the tube, one of the hardware detents from the dx-d600 had fallen off the overhead rail.Agfa field service immediately responded to the call and determined the detent had not been corrected with additional self-drilling screws, as described in a previous mandatory upgrade.In (b)(4) 2014, new screws were introduced by (b)(4), agfa's supplier, to install the detents to the rails on identified dx-d600 systems.The new screws are self-drilling and replaced some of the hex socket threaded rod used before.This was part of the upgrade to improve detent fixation.Agfa service successfully installed the self-drilling screws to the rails on the system for this customer and the mandatory correction was confirmed on (b)(4) 2016.The system is now working as intended.There has been no reported harm to patient or user during this event.

Manufacturer Narrative

The description of the event was incorrect with reference to one of the hardware detents from the dx-d600 falling off the overhead rail.This supplemental report #2 is being submitted to correctly provide the description of the overall event and to provide the root cause.An event of the detent marker dropping down from the overhead rails of one dx-d 600 unit occurred at the site on (b)(6) 2016.The customer reported that while moving the tube, one of the detent markers from the dx-d 600 dropped down from the overhead rail.Agfa field service immediately responded to the call and successfully installed self-drilling screws to the detent markers on the system for this customer.This correction was confirmed on february 27, 2016.The system is now working as intended.The root cause was identified by march 31, 2016, during the investigation by agfa and the supplier.Self-drilling screws that were included in the detent marker kits were not installed by the service engineer, only the threaded rods were used.The use of these self-drilling screws is not described in the service manuals delivered by the supplier.A decision was made to inspect fixation/mounting of parts on the rail/ceiling suspension for all dx-d 600 units via a mandatory service bulletin.The dx-d 600 service manual will be updated and service instructions/actions will be described in the msb.This correction and any additional reporting will be reported to fda via 21 cfr 806 reporting.There has been no reported harm to patient or user during this event.

Event Description

• 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: 5511183
• MDR Text Key: 41232764
• Report Number: 9616389-2016-00003
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• 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: 5R2YR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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