MalfunctionKPZ
VERIFLEX
Received Apr 2, 1998 · Event occurred Oct 15, 1997
Report 1121753-1998-00013 · MDR key 161701
Device
Generic name
Record And Verify System
Manufacturer
Nucletron BvModel number
VERSION 2.04Catalog number
109.020
Lot number
NA
Product problems
- Computer Software Problem
- Application Program Problem: Parameter Calculation Error
Patient
NA
- Overdose
Narrative
Description of Event or Problem
DURING THE FIRST TREATMENT OF A PT, TWO OF TWO FIELDS WERE TREATED. THE THERAPIST THEN PREPARED TO TAKE A PORT FILM. THE ACCELERATOR ATTEMPTED TO DELIVER 250 MU, BUT WHEN THE THERAPIST REALIZED THE ERROR, 100 MU HAD BEEN DELIVERED. THIS EXCEEDED THE TOTAL PRESCRIBED MU BY 100. IF ESC KEY IS PRESSED ON THE VERIFLEX KEYBOARD, AFTER RAD-ON AND BEFORE RAD-OFF, VERIFLEX WILL FAIL TO RECORD TREATMENT AND WILL NOT REGISTER THE TREATMENT AS BEING COMPLETE. IT IS THEN POSSIBLE TO RE-TREAT THE SAME FIELD.
Remedial action
- Notification