Philips received a complaint on the efficia dfm100 defibrillator indicating that device is not delivering the shock.There was no patient involvement.Based on the information available and the testing conducted, the cause of the reported problem was due to the defective dfm100 assy therapy.The reported problem was confirmed.The device was operational after defective dfm100 assy therapy is replaced with a new one.The investigation concludes 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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