PSI-TEC III INFILTRATOR
Received Jun 29, 2006 · Event occurred Feb 9, 2006
Report 2025576-2006-00004 · MDR key 736919
Device
Generic name
Infiltration Pump
Manufacturer
Byron Medical, Inc.Model number
PT-PINF-IIICatalog number
PT-PINF-III
Lot number
*
Product problems
- Loss of Power
- Failure to Power Up
Patient
*
- Electric Shock
Narrative
Description of Event or Problem
THE DR. INDICATES THAT THE O.R. NURSE WENT TO ADJUST THE SETTING ON THE UNIT, AND IT GAVE HER A "SMALL ELECTRICAL JOLT". IMMEDIATELY AFTER, THE UNIT STOPPED WORKING COMPLETELY. THE SWITCH WILL NOT POWER UP THE UNIT OR THE FOOT PEDAL. THE DR. STATED THAT THIS WAS NOT A SIGNIFICANT EVENT.
Additional Manufacturer Narrative
INITIAL EVALUATION OF THE UNIT INDICATED THAT THE DEVICE HAD NO POWER WHEN PROPER CONNECTED. VISUAL EVALUATION REVEALED THAT THE THREE SCREWS ON THE BACK OF THE DEVICE WERE RUSTY, INDICATED THAT FLUID HAD BEEN IN THE LOCATION FOR SOME TIME. TWO OF THE THREE SCREWS UNDER THE CAM AND BEARING APPEAR TO HAVE BEEN REMOVED AS THEY WERE HITTING THE BOTTOM OF THE BEARING. THIS INDICATES THAT THE TOP OF THE UNIT HAD BEEN REMOVED AT ONE TIME. FURTHER ELECTRICAL EVALUATION REVEALED THAT, THE FUSE HAD BLOWN DUE TO WATER IN THE MOTOR. WATER CAN ONLY GET TO THIS AREA IF THE UNIT HAD BEEN IMMERSED IN LIQUID. PAGE 7 OF 12 IN OPERATIONS MANUAL INDICATES TO THE USER IN A WARNING STATEMENT NOT TO IMMERSE IN LIQUID, AND NOT TO OPEN THE CASE.