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.

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.