JUPITER, ARTIS and TruSystem 7500 에 대한 현장 안전성 서한

Field Safety Notice

2015-01-12

Slovenia

AMPMDRS

Trumpf medical has received reports that in some cases the above operating tables were moving automatically and without conscious use of the remote control. no injuries to patients or users. reported cases suddenly occurred during preparation or surgery. through individual investigations, each time it was determined that the problem was a button on the remote control that was mechanically damaged by external influences. the defective key corresponded to the reported direction of movement each time. key injuries may have occurred due to e.G. collision with other objects or compression between moving parts. as a result, the remote control can, at any time, permanently or temporarily transmit a movement command at a time when a particular shake or movement occurs. the operating table cannot differentiate the throw with such and the desired movement commands. based on investigations, trumpf medical has determined that remote controls were used controls that show clear damage and are therefore no longer permitted to use. automatic movement can be prevented by proper inspection before use.