DIALOG PLUS
Received Feb 29, 2008 · Event occurred Dec 18, 2007
Report 2523676-2008-00006 · MDR key 1006515
Device
Generic name
Hemodialysis System
Manufacturer
B. Braun Medical, Inc.Model number
NACatalog number
710500K
Lot number
30058
Product problems
- Unknown (for use when the device problem is not known)
Patient
Not reported
- Electric Shock
Narrative
Description of Event or Problem
AS REPORTED BY THE USER FACILITY: NURSE TOUCHED BACK OF MACHINE AND GOT A SHOCK. MACHINE WAS REMOVED FROM FLOOR FOR INSPECTION. ADDITIONAL INFO PROVIDED BY THE FACILITY INDICATED THAT THE SHOCK WAS BRIEF, NOT CONSTANT, AND WAS POSSIBLY RELATED TO STATIC.
Additional Manufacturer Narrative
A B. BRAUN CUSTOMER ENGINEER COMPLETED INSPECTION OF THE MACHINE INCLUDING GROUND AND ELECTRICAL CHECKS. ALL PARAMETERS WERE WITHIN SPECIFICATION. AN ELECTRICIAN INSPECTED THE ELECTRICAL OUTLET AND REPORTED THAT THERE WERE NO PROBLEMS. PROBLEM IS SUSPECTED TO BE RELATED TO A STATIC SHOCK SINCE THE SHOCK WAS BRIEF AND COULD NOT BE REPEATED. THE MACHINE WAS RETURNED TO SERVICE AFTER INSPECTION WAS COMPLETED, WITH NO FURTHER PROBLEMS.
Remedial action
- Other