MalfunctionIXY
VS200 WALL STAND
Received Apr 12, 2019 · Event occurred Oct 16, 2014
Report 1418964-2019-00013 · MDR key 8510243
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
DURING A RECENT FDA INSPECTION, IT WAS OBSERVED THAT WE DID NOT SUBMIT A MEDICAL DEVICE REPORT FOR ADDITIONAL INSTANCES THAT WERE ALREADY REPORTED. THIS REPORT IS TO CORRECT THAT OBSERVATION.
Description of Event or Problem
THE COUNTERWEIGHT HOLD DOWN BLOCK SEPARATED FROM MAIN COUNTERWEIGHT ASSEMBLY. NO INJURIES REPORTED.
Remedial action
- Repair