MalfunctionEIA
VACSTAR 50
Received Aug 22, 2016 · Event occurred Jul 25, 2016
Report 2428225-2016-00001 · MDR key 5894780
Device
Product problems
- Misassembled
- Misconnection
- Device Issue
- Misassembled
- Misconnection
- Device Issue
Patient
Not reported
- Electric Shock
- Electric Shock
Narrative
Additional Manufacturer Narrative
CORRECTIVE ACTION IS TO UPDATE THE USER'S MANUAL FOR ALL HARD WIRED INSTALLATIONS TO INCLUDE ADDITIONAL REQUIREMENTS FOR GROUNDING PER CAPA (B)(4).
Description of Event or Problem
TECHNICIAN CALLED TO REPORT AN ELECTRICAL SHOCK FROM VS50 UNIT. WHILE SERVICING VACUUM, TECHNICIAN LEANED AGAINST FRAME OF VACUUM AND RECEIVED A SHOCK. SUPPLY CIRCUIT WAS A 10 AMP BREAKER, WIRE SIZE UNKNOWN LEADING TO A BOOST TRANSFORMER RATED AT .50 KVA. THERE WAS NO CONTINUOUS GROUNDING FROM VACUUM TO MAIN PANEL.
Remedial action
- Other