SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE

Additional Manufacturer Narrative

THE SYSMEX UF-1000I INSTRUCTIONS FOR USE (IFU), WARNS THE USER: "SHOULD THE INSTRUMENT EMIT ANY UNUSUAL ODORS OR SMOKE, TURN THE MAIN SWITCH OFF IMMEDIATELY AND UNPLUG THE POWER CABLE. CONTACT SYSMEX TECHNICAL REPRESENTATIVE. USING THE INSTRUMENT ANY FURTHER BEARS THE RISK OF FIRE, ELECTRICAL SHOCK OR PERSONAL INJURY". THE USER APPROPRIATELY CONTACTED SIEMENS HEALTHCARE DIAGNOSTICS UPON NOTICING THE BURNING ODOR. THE WIRING CORD IS MADE OF FLAME RESISTANT MATERIALS, BUT EXCESSIVE HEAT FROM A MALFUNCTION POSES A RISK OF INHALATION OF SMOKE AND/OR HARMFUL VAPORS FROM SCORCHED MATERIALS. THE WIRING CORD IS NOT ACCESSIBLE TO THE USER, REDUCING POTENTIAL HARM. THE WIRING CORD CONNECTS THE FIXED BARCODE READER TO THE I/O CONTROLLER (B)(4). THE MAXIMUM VOLTAGE TRAVELING THROUGH THE WIRING CORD IS 5V. THE LOW VOLTAGE REDUCES THE POTENTIAL FOR SHOCK. NO USER HARM INCURRED. THE FSE REMOVED THE WIRING CORD AND REPLACED THE TUBING TO RESOLVE THE ISSUE. THE WIRING CORD WAS NOT AVAILABLE FOR FURTHER INVESTIGATION. IT WAS DETERMINED A SHORT CIRCUIT OCCURRED BUT ROOT CAUSE OF THE SHORT CIRCUIT (DAMAGE TO THE CORD AND TUBING) WAS UNDETERMINED.

Description of Event or Problem

THE USER CONTACTED SIEMENS HEALTHCARE DIAGNOSTICS REPORTING A BURNING ODOR EMANATING FROM THE ANALYZER. THE SIEMENS REPRESENTATIVE INSTRUCTED THE USER TO POWER OFF AND UNPLUG THE ANALYZER. THE USER REPORTED THE BURNING ODOR WAS ELIMINATED AFTER THE ANALYZER WAS POWERED OFF. A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND WIRING CORD 3735 AND SURROUNDING TUBING WAS BURNT. NO SMOKE OR OPEN FIRE WAS OBSERVED. NO USERS SOUGHT MEDICAL ATTENTION DUE TO THE BURNING ODOR. NO USER OR PATIENT HARM INCURRED.