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

Model Number DX-D600

Device Problems Computer Software Problem (1112); Nonstandard Device (1420); Unintended Movement (3026)

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

Event Date 05/17/2014

Event Type  malfunction  

Event Description

A retrospective review was performed by agfa for events, from years 2012 to march 20, 2015, related to unexpected movement of dx-d600 systems.Vigilance activity to report identified events was implemented march 2015.The following event was identified and is being reported to the fda.On (b)(6) 2014, the customer reported to agfa, that on (b)(6) 2014, during a patient exam, there was another event of uncontrolled movement of the wall bucky of their dx-d600 system while making adjustments to the overhead tube crane (otc).A radiographer moved the otc in the upward direction and the wall stand moved in the downward direction in a steady quick motion to the bottom.There were no reports of harm to any patient or user.The system was placed into manual mode during the investigation.Updates and part exchanges had already been performed on this system in november/december 2013, with assistance from (b)(4), agfa's supplier.Further investigation in review of the log files, revealed a software problem in the nova firmware.A new software upgrade was performed on the system for this event.The system has been corrected.Agfa has initiated the following corrective actions related to unintended movement of dx-d600 systems to address these unexpected movements.On july 2, 2014, vigilance activity was initiated to report corrections to fda (fda # z-2175-2014) for a mandatory software upgrade of dx-d600 full automatic systems to version 3.6 to prevent unexpected system movements.On december 15, 2014, vigilance activity was also initiated to report additional corrections to fda in the same (fda # z-2175-2014) to implement the mandatory upgrade of semi-automatic dx-d600 systems to version 3.6 to prevent unexpected system movements and to implement the mandatory upgrade of analog manual dx-d600 systems to an improved detent fixation.

Manufacturer Narrative

• 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 26 40; BE B 2640
• Manufacturer (Section G): AGFA HEALTHCARE N.V.; septestraat 27; mortsel, belgium B 26 40; BE B 2640
• Manufacturer Contact: deborah huff ; 10 south academy street; greenville, SC 29601 ; 8644211754
• MDR Report Key: 4656497
• MDR Text Key: 17201556
• Report Number: 9616389-2015-00036
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/03/2015

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?: Yes
• Initial Date Manufacturer Received: 05/19/2014
• Initial Date FDA Received: 04/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1