The failure described by the customer could be reproduced at maquet.A supplier complaint revealed a problem with the offset of the plastic socket.It may be possible that in some cases the plastic socket is not pressed deep enough into the housing so that not both pins secure the plastic socket in the housing.Further tests by the supplier showed that when just one pin is fixed the connection meets its specification.In the instructions for use (ifu) the connection to mains supply and the detachment of the mains cable is described.For detaching, it is stated: ¿detach the plug at the main socket.Detach the mains cable from the mobile operating table.¿ this means the customer first has to disconnect the cable from the mains socked (from the wall) and then pull the plug out of the table.The user confirmed that the table was not connected from the main socket first.Just a combination of not correct assembled cold-device-plug and not following the ifu can lead to the described failure.Field safety corrective action (fsca) capa (b)(4) was started for this issue.As part of this fsca a field safety notice (fsn) was sent to the customer.In this fsn the customer of the table was informed that the ifu has to be followed.The customer has confirmed that the fsn was read, understood and that all users within the facility were informed as well as the note concerning the disconnection order would be followed.Further, in the fsn it is stated that a field action was initiated to modify the affected sockets.This modification was not yet performed for the affected table, when the incident occurred.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.
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