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

Model Number DX-D600

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/23/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

An event of a single dx-d600 system occurred at the site on (b)(6) 2016.Agfa became aware on june 24, 2016.A patient was being imaged for a shoulder exam using the upright wall stand.When the tube was auto positioned for the exam the tube started to move as it normally would into position but then with increasing speed, moved inward towards the wall stand almost hitting the patient.The technologist was able to pull the patient out of the way of the moving tube.Investigation is underway to determine root cause and any corrective action as needed.There has been no reported harm to patient or user during this event.

Manufacturer Narrative

This supplemental report is to report preventive actions and the root cause.On (b)(4) 2016 as a preventive action, the agfa field service engineer replaced the longitudinal potentiometer and tachometer.The investigation by agfa and the supplier determined there was not a hardware issue.The probable root cause was identified by (b)(4) 2016, during the investigation by agfa and the supplier.When operating the unit the system user pressed by mistake the parking button instead of the autocenter button.The customer will use a new workflow to prevent this from occurring again.The system user will rotate the tube head to a more normalized position before auto centering.The unit is operating as intended with no additional issues.There have been no reports of harm to users or patients during these events.

• Brand Name: DX-D600 -DXD IMAGING PACKAGE
• Type of Device: DX-D600 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: 5762499
• MDR Text Key: 49394929
• Report Number: 9616389-2016-00004
• 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
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• 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: 06/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• 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