It was reported to philips that device has ecg equipment intermittent malfunction.Patient involvement information is currently unknown, but no reported adverse event.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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Philips received a complaint on the dfm100 indicating that the ecg still can be detected, however alarm with ecg equipment malfunction popup on the screen.Device was in clinical use at time of event, no patient harm reported.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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