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U.S. Department of Health and Human Services

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

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AGFA HEALTHCARE N.V. DX-D600 -DXD IMAGING PACKAGE DX-D600 SYSTEM Back to Search Results
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.
 
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Brand NameDX-D600 -DXD IMAGING PACKAGE
Type of DeviceDX-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 Key5762499
MDR Text Key49394929
Report Number9616389-2016-00004
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112670
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDX-D600
Device Catalogue Number5R2YR
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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