ABX PENTRA 400 ISE
Received Aug 20, 2015 · Event occurred Jul 23, 2015
Report 2086725-2015-00004 · MDR key 5019402
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
ON (B)(6) 2015 THE CUSTOMER CALLED A HORIBA MEDICAL SERVICE REPRESENTATIVE AND INDICATED THAT THE COMPRESSOR CONNECTED TO THE PENTRA 400 CHEMISTRY ANALYZER HAD MALFUNCTIONED AND THAT THE CUSTOMER NOTED THE COMPRESSOR FUSE/FUSE HOUSING AND POWER MODULE HAS BURN MARKS. THERE WERE NO PATIENT SAMPLES INVOLVED AND NO INJURY ASSOCIATED WITH THE REPORTED EVENT. A HORIBA MEDICAL FSR WAS DISPATCHED TO DETERMINE IF THE ANALYZER WAS MALFUNCTIONING. THE FSR WENT ON SITE AND NOTED THE CUSTOMER HAD INSTALLED A WRONG FUSE ON THE COMPRESSOR. FSR REPLACED THE BURNED FUSE, THE POWER MODULE AND ADVISED CUSTOMER OF THE CORRECT FUSE TO BE USED WITH THE COMPRESSOR. FSR CONFIRMED THE COMPRESSOR FUNCTIONING CORRECTLY AFTER THE PARTS REPLACEMENT. THERE IS NO REPORT OF INJURY OR ILLNESS IN CONNECTION WITH THIS INCIDENT. THE BURNED PARTS WERE DISCARDED AT THE CUSTOMER SITE.