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

Model Number DX-D600

Device Problems Component Falling (1105); Nonstandard Device (1420); Maintenance Does Not Comply To Manufacturers Recommendations (2974); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2015

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 march 2015.The following event was identified and is being reported to the fda.The customer reported that one of the hardware detents from the dx-d600 had fallen off the ceiling rail and hit a staff member in the head.The staff member was sent to receive medical attention from a doctor after the event and returned to work after the doctor visit to complete their shift.Agfa field service responded to the call and was onsite the same day as the event.The ceiling area where the part fell was examined and it was determined the detent had not been fixed with additional self-tapping screws, as part of the upgrade to version 3.6.Agfa service successfully secured the part and the final upgrade is underway for this site.The root cause is related with the screws (threaded rod) used to fix the mechanical detents to the rails and were not tight enough and became loose with the use of the system.In (b)(4) 2014, new screws were introduced by (b)(4), agfa's supplier, to install the detents to the rails.The new screws are self-drilling and replace some of the hex socket threaded rod used before.This is part of the upgrade to improve detent fixation.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.There were no other reports of harm to any other patients or users during 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, 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: 4654502
• MDR Text Key: 5681804
• Report Number: 9616389-2015-00044
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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?: Yes
• 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: 02/02/2015
• Initial Date FDA Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1