VS200 WALLSTAND
Received Jul 30, 2019 · Event occurred Jun 20, 2019
Report 1418964-2019-00018 · MDR key 8843401
Device
Generic name
Radiographic Cassette Holder
Manufacturer
Del Medical Inc.Model number
VS200Catalog number
110-5010G8
Lot number
N/A
Product problems
- Break
- Fracture
- Material Integrity Problem
- Break
- Fracture
- Material Integrity Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE RETURNED PARTS WERE EXAMINED AGAINST SAMPLES OF PARTS WITH SHOCK DAMAGE AND OVER TORQUE DAMAGE. MAGNIFIED EXAMINATION INDICATED CHARACTERISTICS MORE IN COMMON WITH SHOCK DAMAGE THAN OVER TORQUE DAMAGE. BASED ON THIS EXAMINATION IT APPEARS THIS ISSUE WAS CAUSED BY SOME EXTERNAL SHOCK TO THE UNIT EITHER DURING ORIGINAL TRANSPORTATION, INSTALLATION OR OTHER SUBSEQUENT MOVEMENT. NOTE: THIS REPORT WAS ORIGINALLY SUBMITTED ON 07/11/2019 AND WAS UNSUCCESSFUL DUE TO TECHNICAL DIFFICULTIES. THOSE DIFFICULTIES HAVE BEEN CORRECTED AND THIS REPORT IS BEING SUBMITTED TODAY.
Description of Event or Problem
WHILE RELOCATING THE CASSETTE HOLDER, THE COUNTERWEIGHT BOLT SEPARATED FROM THE WEIGH RESULTING IN THE CASSETTE CARRIAGE NEEDING TO BE GUIDED TO THE FLOOR. THERE WERE NO INJURIES REPORTED.
Remedial action
- Repair