inforMED
MalfunctionEIA

VACSTAR 50

Received Aug 22, 2016 · Event occurred Jul 25, 2016

Report 2428225-2016-00001 · MDR key 5894780

Device

Generic name

Dental Vacuum System

Model number

VS50

Catalog number

VS50

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