It was reported to philips that ecg waveform was inconsistent with the patient's symptoms when it's used to monitor the ecg waveform changes.Device was in clinical use 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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This report is based on information provided by philips authorized service provider (asp) and has been investigated by the philips complaint handling team.Philips received a complaint on the dfm100 indicating that ecg waveform was inconsistent with the patient's symptoms.Device was in clinical use when the reported problem was discovered.However, customer immediately use other monitor and there was no patient harm or injury was 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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