STREAMLAB ANALYTICAL WORKCELL

Additional Manufacturer Narrative

SIEMENS FILED AN INITIAL MDR 2517506-2019-00293 ON 19-JUL-2019. ADDITIONAL INFORMATION (23-JUL-2019): SIEMENS WAS NOT PROVIDED THE DATA REQUESTED IN ORDER TO PERFORM THE INVESTIGATION. SIEMENS CUSTOMER SUPPORT ENGINEER (CSE) WENT ONSITE AND PERFORMED THE FOLLOWING ACTIONS. IDENTIFIED A FEW GROUNDING CONNECTIONS THAT WERE NOT TIGHTENED CORRECTLY. THE CSE ALSO ENSURED THAT THE GROUNDING KIT WAS IN PLACE, ALL SCREWS TIGHTENED, AND ALL GROUND WIRES WERE REBUILT. ADDITIONALLY, SOME RACKS WERE REPLACED DUE TO THE PLASTIC PROTECTION BEING DEFECTIVE AND SOME METAL PARTS WERE ACCESSIBLE. ALL NECESSARY ACTIONS WERE IMPLEMENTED SUCCESSFULLY, AND NO ISSUES HAVE BEEN OBSERVED AFTER COMPLETION OF THESE ACTIONS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Additional Manufacturer Narrative

THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). CUSTOMER STATED THAT AN OPERATOR OBSERVED AN ELECTRIC ARC MULTIPLE TIMES WHEN TOUCHING THE IOM (INPUT/OUTPUT MODULE) RACK ON THE STREAMLAB CORE UNIT AT THE CUSTOMER'S SITE. THE GROUND KIT WAS INSTALLED AND CUSTOMER STATED THAT A STATIC CHARGE WAS OBSERVED. THE CAUSE OF THE INCIDENT IS UNKNOWN. SIEMENS IS INVESTIGATING THE ISSUE.

Description of Event or Problem

THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT THAT AN OPERATOR OBSERVED AN ELECTRIC ARC MULTIPLE TIMES WHEN TOUCHING THE IOM (INPUT/OUTPUT MODULE) RACK ON A STREAMLAB CORE UNIT AT THE CUSTOMER'S SITE. ALL POWER SHUT DOWN ON THE STREAMLAB UNIT. THE CUSTOMER REPORTED THERE WAS A DELAY IN PATIENT TESTING DUE TO THE CUSTOMER HAVING TO RESTART THE STREAMLAB UNIT AFTER THE POWER SHUT DOWN ON THE UNIT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.