During review of complaints performed on 12th june 2017 for one of the reportable cases we became aware of the similar issues which have been registered in our internal system in the past.As the revision of the recorded information shown that previous case were similar we decided to report it retrospectively.The malfunction occurred on a air glide system (ags) called unloading conveyor.This is not a medical device.It is an accessory to getinge 88-series and 86-series washer disinfector device.The conveyor loads and unloads racks with material to be disinfected, into and out of the disinfector.That it is all it does and in that way it has no effect on the core performance of the disinfector device.Getinge received customer complaint where, as stated, docking pin located at the end of the unloader stuck in wrong position.As result carts transferred from the washer disinfector fell down on the floor.Moreover it was stated that the docking assy on the loading table and unloading shuttle malfunctioned and need to be replaced.The event did not result in any injury.It was established that when the event occurred the unloader working in the system with the washer-disinfector device has not met its specification and it contributed to the event.When the event occurred the device was being used by the user.During the investigation it was found that the event occurred as a result of two factors: the program needs an override action to be performed by the user, by the pressing the reset button.The reset is done by the operator if the cart is not moved to the unloader from the washer disinfector or any other problem with the cart transferring.The end pin of the unloader needs to be stuck in the down position.When the pin is in down position there is no mechanical protection to keep the cart on the conveyor, therefore when the cart reaches the edge of the conveyor is not mechanically stopped and it falls off.It was concluded that when both of mentioned factors appear in the same time the cart could not be stopped at the end of the conveyor and could fall down on the floor.(b)(4).
|
On (b)(6) 2015 getinge received customer complaint where, as stated, docking pin located at the end of the unloader stuck in wrong position.As result carts transferred from the washer disinfector fell down on the floor.Moreover it was stated that the docking assy on the loading table and unloading shuttle malfunctioned and need to be replaced.The event did not result in any injury.
|