GETINGE 46-SERIES

Description of Event or Problem

SMOKE/FIRE WAS OBSERVED COMING FROM A GETINGE MODEL 46-4 WASHER DISINFECTOR DURING USE. THE WASHER WAS APPROX 35-40 MINUTES INTO A 70 MINUTE CYCLE WHEN STAFF OBSERVED SMOKE/FIRE. THE USER'S TURNED OFF THE POWER TO THE UNIT AND SPRAYED WITH A DRY POWDER EXTINGUISHER.

Additional Manufacturer Narrative

DEVICE WAS EVALUATED REMOTELY (NOT RETURNED TO MANUFACTURER) VIA INVESTIGATION REPORTS AND PHOTOGRAPHS FROM GETINGE (B)(4)., A SERVICE UNIT LOCATED IN (B)(4). IT WAS CONCLUDED THAT THE OVERHEAT PROTECTION SYSTEM FAILED/DELAYED RESPONSE TO AN OVERHEAT CONDITION. A VOLUNTARY DEVICE CORRECTION OF GETINGE MODEL 46-4 WASHER DISINFECTORS WAS REPORTED TO U.S. FDA ON (B)(4) 2013 (RECALL NUMBER NOT YET ASSIGNED). THIS CORRECTION WAS INITIATED TO ADDRESS TWO CONDITIONS. A POTENTIAL TRIGGER FOR OVERHEATING; (ROOT CAUSE) - INADEQUATE OVERHEAT PROTECTION SYSTEM COMPONENT. A COMPONENT (SHUNT TRIP) SELECTED FOR THE OVERHEAT PROTECTION SYSTEM DOES NOT MEET THE REQUIRED PARAMETERS (CONTROL VOLTAGE) WHERE/WHEN OVERHEATING OCCURS. THE CORRECTION ENTAILS - INSPECTING THE SETTING OF A SOFTWARE FUNCTION THAT CAN BE UTILIZED DURING SERVICING OF A UNIT TO SKIP WASH PHASES. THIS IS A PASSWORD PROTECTED FUNCTION BUT IF LEFT IN THE ENABLED STATE, A USER CAN INADVERTENTLY ACTIVATE THE HEATING ELEMENT WITH NO WATER IN THE CHAMBER. THE DEVICE CORRECTION ACTION INCLUDES INSPECTING THAT THIS FUNCTION IS NOT ENABLED. THE INSTALLATION OF A NEWER DESIGN OF OVERHEAT PROTECTION SYSTEM THAT UTILIZES A HEATING ELEMENT WITH INTEGRAL THERMAL FUSES THAT MEET THE REQUIRED OVERHEAT PARAMETERS. RECALL NUMBER NOT YET ASSIGNED.