STREAMLAB® ANALYTICAL WORKCELL
Received Nov 3, 2017 · Event occurred Oct 10, 2017
Report 2517506-2017-00802 · MDR key 7000750
Device
Generic name
Streamlab® Analytical Workcell
Manufacturer
Siemens Healthcare Diagnostics IncModel number
STREAMLAB® ANALYTICAL WORKCELLProduct problems
- Mechanical Problem
- Mechanical Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT THE SMOKE. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. SERVICE WAS PERFORMED OVER MULTIPLE VISITS. THE CSE TESTED THE CENTRIFUGE FUNCTIONALITY AND IT WAS PROPER. THE CSE INSPECTED THE CENTRIFUGE MODULE AND HAD ISSUES WITH CENTRIFUGE ROBOT ROTATIONAL. THE CSE REPLACED THE ROTATIONAL AND VERTICAL STEPPER BOARDS. THE CSE INSTALLED STEPPER DRIVER BOARDS. THE CSE REPLACED STEPPER DRIVER BOARDS FOR CENTRIFUGE ROBOTS Y AND Z. THE CSE VERIFIED OPERATION OF CENTRIFUGE ROBOT, WHICH WAS ACCEPTABLE. THE CSE FOUND CONDENSATION INSIDE AIRLINES AND AIR COMPRESSOR RUNNING NONSTOP. THE CSE REPLACED START UP AND UNLOADER VALVES ON AIR COMPRESSOR AND WATER TRAP ON INCOMING AIRLINE. THE CSE TESTED STREAMLAB IN DIAGNOSTICS, WHICH PASSED. THE CSE WATCHED STREAMLAB PROCESS SAMPLES. THE CAUSE OF THE SMOKE IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN MANUFACTURING SPECIFICATIONS. NO FURTHER EVALUATION OF DEVICE IS REQUIRED.
Description of Event or Problem
SMOKE WAS EMITTED FROM A STREAMLAB CORE UNIT CENTRIFUGE. THE CENTRIFUGE WAS POWERED OFF. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE EVENTS DUE THE SMOKE.