ABX PENTRA 400 ISE
Received Nov 5, 2015 · Event occurred Oct 20, 2015
Report 2086725-2015-00007 · MDR key 5205696
Device
Product problems
- Electrical /Electronic Property Problem
- Electrical Shorting
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER CALLED HORIBA MEDICAL TECH SUPPORT REPRESENTATIVE AND REPORTED THAT THE ABX PENTRA 400 CHEMISTRY ANALYZER DISPLAYED COMPRESSOR OVERLOAD ERROR MESSAGE AND THE CUSTOMER WAS UNABLE TO RESTART THE ANALYZER. FSR WAS DISPATCHED TO EXAMINE THE ANALYZER AND UPON INVESTIGATION FOUND BURN MARKS ON THE POWER ENTRY MODULE AND POWER CABLE ON THE COMPRESSOR THAT WAS CONNECTED TO THE P400 ANALYZER. FSR PERFORMED SERVICE ON THE COMPRESSOR, REPLACED THE BURNED POWER MODULE CONNECTOR AND POWER CABLE, PERFORMED PREVENTIVE MAINTENANCE SERVICE ON THE ANALYZER AND CONFIRMED THE SYSTEM WAS FUNCTIONING CORRECTLY AFTER THE PARTS REPLACEMENT AND SERVICE. THE BURNED PARTS WERE DISCARDED AT THE CUSTOMER SITE AND WERE NOT AVAILABLE FOR ANALYSIS. THERE WERE NO REPORTS OF ANY IMPACT TO PATIENT MANAGEMENT DUE TO THIS ISSUE. THERE WERE NO INJURIES OR DAMAGE TO THE SURROUNDING LAB ENVIRONMENT. THE ANALYZER CONFORMS TO THE UL STANDARDS.