MalfunctionIYY
VERTEX
Received Aug 16, 1999 · Event occurred Jul 18, 1999
Report 2916556-1999-00077 · MDR key 236804
Device
Generic name
*
Manufacturer
Adac LaboratoriesModel number
VERTEX PLUS MANUALCatalog number
2149-3001A
Lot number
NA
Product problems
- Unintended System Motion
- Use of Device Problem
- Other (for use when an appropriate device code cannot be identified)
- Locking mechanism failure
Patient
*
Narrative
Description of Event or Problem
A RING LOCK ERROR OCCURRED THAT REQUIRED THAT RECOVERY BE INITIATED IN SVC MODE. THE PROCEDURE WAS INCORRECTLY PERFORMED BY THE FSE RESULTING IN HEAD 2 SWINGING FREELY. THERE WAS NO PT IN THE EQUIPMENT AT THE TIME OF THE EVENT. THE OPERATORS' MANUAL STATES THAT THE PT SHOULD NOT BE ON THE TABLE DURING OPERATION OF THE RING LOCKS. THERE WERE NO INJURIES TO USERS, PTS, OR OTHER PERSONNEL.
Remedial action
- Repair
- Modification/Adjustment