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); Device Operates Differently Than Expected (2913); Unintended Movement (3026)

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

Event Date 05/23/2013

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 19, 2014.The following event was identified and is being reported to the fda.A complaint was opened (b)(6) 2013 in which the customer reported unexpected movement of the dx-d600 z-axis movement.The customer reported unexpected movement of the dx-d600 overhead tube crane (otc) towards the rear of the room and hitting the stop with enough force to cause concern to the patient.After an examination on the wallstand with the bucky tilted, the user used the auto positioning to place the tube for the next exposure.During the final vertical movement, the tube fell down into position, as if the brakes didn't work.The patient was lying in bed inside the room (it was his 2nd exposure) and the tube fell down near his head.There were no reports of harm to any patient or user.Agfa replaced tachometer, motor, gauge pcb and vertical pcb and system was operational and system movement was as expected.Root cause was determined to be the tachometer signal was loose that made the servo electronics to perform movement to its maximum speed capability to the intended final destination.On june 30, 2014, vigilance activity was initiated to report corrections to health canada (hc# 10168) for a mandatory software upgrade of dx-d600 full automatic systems to version 3.6 to prevent unexpected system movements.On december 12, 2014, vigilance activity was also initiated to report additional corrections to health canada (hc# 10168) 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

Manufacturer Narrative

The cover letter attached in the initial report was dated march 20, 2014 and should read date of march 20, 2015.Omitted selection.Selection should be "product problem".Statement in 2nd sentence reads " vigilance activity to report identified events was implemented (b)(6) 2014." the year should read 2015.Report source should be checked as : company representative.

Event Description

Statement in 2nd sentence reads " vigilance activity to report identified events was implemented (b)(6) 2014." the year should read 2015.

• 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: 4620865
• MDR Text Key: 5591421
• Report Number: 9616389-2015-00006
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K112670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2015

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: 5430/110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2013
• Initial Date FDA Received: 03/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1