MAMMOLUX 1360
Received Mar 21, 2006 · Event occurred Feb 20, 2006
Report 2953690-2006-00001 · MDR key 690609
Device
Generic name
Motorized X-ray Viewer
Manufacturer
R2 Technology, Inc.Model number
MLX 1360Catalog number
MD 4020
Lot number
*
Product problems
- Loss of Power
Patient
*
- Bruise/Contusion
- Injury
Narrative
Description of Event or Problem
DURING ONE OF THESE PROCESSES THE TECHNICIAN'S ATTENTION WAS DIVERTED AND HER ARM WAS CAUGHT IN THE UPPER BELT INTAKE AREA. THE MOTORIZED VIEWER SHUT OFF AUTOMATICALLY. ONCE THE VIEWER WAS STOPPED, THE TECH WAS ABLE TO REMOVE HER ARM. THE TECH REPORTED "SOFT TISSUE DAMAGE" (BRUISING) TO HER ARM. HER ARM WAS PLACED IN A SLING. SHE MISSED TWO DAYS OF WORK BEFORE RETURNING TO NORMAL DUTIES. THE TECHNICIAN'S INJURY HAS SINCE RESOLVED COMPLETELY. THE DEVICE IS LABELED USING INTERNATIONAL SYMBOLOGY WARNING USER TO BE AWARE OF THE DANGER OF GETTING HANDS CAUGHT IN THE MOVING PARTS OF THE DEVICE.