MalfunctionFWY
OPERON
Received Oct 26, 2012 · Event occurred Sep 5, 2012
Report 8010153-2012-00009 · MDR key 2843846
Device
Product problems
- Device Operates Differently Than Expected
- Unintended Movement
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING A SURGICAL PROCEDURE WITH A PATIENT ON THE TABLE, THE TABLE WAS REPORTED TO HAVE MOVED INTO TILT AND UNLOCKED WITH NO ACTIVATION OF THE HAND CONTROL. NO INJURY WAS REPORTED.
Additional Manufacturer Narrative
THE TABLE WAS EVALUATED BY A BERCHTOLD FIELD SERVICE REPRESENTATIVE ON (B)(4) 2012. THE PROBLEMS COULD NOT BE DUPLICATED WHEN USING THE ORIGINAL HAND CONTROL, THE REPLACEMENT HAND CONTROL, AND THE SERVICE PROGRAM. THE ORIGINAL HAND CONTROL EXHIBITED SIGNS OF DAMAGE, WAS REPLACED, AND WAS RETURNED FOR EVALUATION.