Philips received a complaint on the efficia dfm100 defibrillator/monitor indicating that it would start up in service mode and the aed cannot be used.There was reportedly no patient involvement.The device was evaluated on site at the bench.The problem was not reproduced but, confirmed that the som circuit board was faulty.The device remains at the customer site and no further evaluation is warranted at this time.Based on the information available and the testing conducted, the cause of the reported problem was a malfunction of the som circuit board.The reported problem was confirmed.The customer replaced the som circuit board to resolve the finding of this issue.It has been concluded that no further action is required at this time.The efficia dfm100 defibrillator, model# 866199, is substantially similar to the heartstart xl+ defibrillator (model # 861290) and will be reported in the united states under device model # 861290.
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