Philips received a complaint on the efficia dfm100 defibrillator indicating that the device was dropped and did not pass the test.There was no patient involvement.Philips bench evaluated the device and determined the code board was defective.Philips bench replaced the code board resolving the reported issue.Based on the information available and the testing conducted, the cause of the reported problem was a malfunction of the code board.The reported problem was confirmed.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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