EV650
Received May 27, 2021 · Event occurred Apr 12, 2021
Report 1418964-2021-00001 · MDR key 11897721
Device
Product problems
- Labelling, Instructions for Use or Training Problem
- Improper or Incorrect Procedure or Method
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
DURING A SERVICE CALL, THE MANUFACTURE'S TECHNICAL SUPPORT REPRESENTATIVE WAS PROVIDING INSTRUCTIONS TO THE THIRD PARTY SERVICE ENGINEER TO SUPPORT DIAGNOSING A PERFORMANCE ISSUE. WHILE THE MANUFACTURERS TECHNICAL SUPPORT REPRESENTATIVE BELIEVED HE WAS CLEARLY COMMUNICATING THAT HE WAS PREVIEWING THE INSTRUCTIONS,THE THIRD -PARTY ENGINEER BEGAN TO PERFORM THE OPERATIONS BEFORE RECEIVING THE COMPLETE SAFETY PRECAUTIONS INSTRUCTIONS. THE MANUFACTURER'S REPRESENTATIVE WAS VERBALLY WALKING THE THIRD-PARTY ENGINEER THROUGH SECTION 5.4 OF THE EV650 SERVICE MANUAL. THIS SECTION CONTAINS A WARNING IMMEDIATELY PRECEDING THE STEP WHERE THE INCIDENT OCCURRED THAT READS "PROCEED WITH CAUTION. THE FOLLOWING STEPS CARRY RISK OF INJURY OR EQUIPMENT DAMAGE. WHEN YOU MAKE THE FOLLOWING CONNECTION THE TABLE WILL BEGIN TO MOVE IMMEDIATELY. THE TABLE WILL STOP ONLY WHEN YOU DISCONNECT THE OVERRIDE CABLE. THE LIMI SWITCHES WILL STOP THE TABLE. TO AVOID DAMAGES STOP THE TABLE AS SOON AS IT IS BACK WITHIN LIMITS RANGE".