MalfunctionIXY
VS200 WALLSTAND
Received Apr 15, 2019 · Event occurred Oct 18, 2018
Report 1418964-2019-00016 · MDR key 8516338
Device
Generic name
Radiographic Cassette Holder
Manufacturer
Del Medical Inc.Model number
VS200Catalog number
110-5010G1
Lot number
N/A
Product problems
- Material Deformation
- Material Deformation
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A CORRECTIVE ACTION INVESTIGATION HAS BEEN INITIATED AND IS STILL ON-GOING.
Description of Event or Problem
BOLT IN COUNTERWEIGHT SHEARED, CASSETTE HOLDER CARRIAGE WAS GUIDED TO THE LOWER END OF VERTICAL TRAVEL BY THE TECHNOLOGIST. NO INJURIES REPORTED.
Remedial action
- Repair