MalfunctionIXY
VS200 WALL STAND
Received Apr 12, 2019 · Event occurred Oct 28, 2014
Report 1418964-2019-00014 · MDR key 8511409
Device
Generic name
Radiographic Cassette Holder
Manufacturer
Del Medical Inc.Model number
VS200Catalog number
110-5010G1
Lot number
N/A
Product problems
- Device Damaged Prior to Receipt by User
- Device Damaged Prior to Receipt by User
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 THT 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 WALL CASSETTE RECEPTOR FELL TO THE FLOOR AND WAS NO LONGER ATTACHED TO THE COUNTERWEIGHT CABLE. NO INJURIES WERE REPORTED.
Remedial action
- Repair