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); Noise, Audible (3273)

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

Event Date 03/17/2014

Event Type  malfunction  

Event Description

A retrospective review was performed by agfa for events, from years 2012 to (b)(6) 2015, related to unexpected movement of dx-d600 systems.Vigilance activity to report identified events was implemented (b)(6) 2015.The following event was identified and is being reported to the fda.Customer reported to agfa when using their dx-d600 system in preparation of a patient exam, they experienced uncontrolled automated vertical movement of the wallstand - overhead tube crane (otc).The rapid movement and noise frightened both the user and the patient.The system was shut down and restarted.The issue could not be reproduced.The customer continued to use the system but did not use the autocenter.Agfa continued the investigation the same day by obtaining log files, checking the brakes and movements of the wallstand to confirm the system was indeed working okay and talking with the customer about the event.Upgrade to the system was planned.There were no reports of harm to any patients or users during this event.Agfa has initiated the following corrective actions related to unintended movement of dx-d600 systems to address these unexpected movements.On july 2, 2014, 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 ((b)(4)) 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: 4654487
• MDR Text Key: 5607638
• Report Number: 9616389-2015-00025
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/02/2015

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: 5430/120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2014
• Initial Date FDA Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1