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 ui module was defective.Philips bench replaced the ui module resolving the reported issue.Based on the information available and the testing conducted, the cause of the reported problem was a malfunction of the ui module.The reported problem was confirmed.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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