MalfunctionNVV
MODEL I 128
Received Sep 12, 2014 · Event occurred Sep 8, 2014
Report MW5038200 · MDR key 4096455
Device
Generic name
Model I 128
Manufacturer
Ann Arbor Digital DevicesModel number
A2D2 LOGO, MODEL I 128 PODIATRYProduct problems
- Mechanics Altered
Patient
61 YR
- Radiation Exposure, Unintended
Narrative
Description of Event or Problem
A PODIATRY X-RAY MACHINER HAS BEEN MODIFIED BY A2D2 TO PRODUCT DIGITAL X-RAYS. THE MODIFICATION HAS CHANGED THE ORIGINAL MANUFACTURERS SID. THE CHANGE IN SID VIOLATES THE LIQUID DISTANCE BETWEEN X-RAY TUBE AND SUBJECT CAUSING AN INCREASE IN RADIATION EXPOSURE TO THE PATIENT. A CANNON REBEL T3I SLR CAMERA IS USED TO CAPTURE THE X-RAY IMAGE. HOW CAN THIS BE SO.