MalfunctionIXY
VS200 WALL STAND
Received Apr 9, 2019 · Event occurred Jul 12, 2013
Report 1418964-2019-00009 · MDR key 8497108
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 Consequences Or Impact To Patient
- No Consequences Or Impact 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 RADIOGRAPHIC TECHNICIAN WAS POSITIONING THE CASSETTE WHEN IT DROPPED DOWN SUDDENLY. NO ONE WAS HARMED.
Remedial action
- Repair