This report is based on information provided by philips field service engineers (fse) and remote service engineer (rse) personnel and has been investigated by the philips complaint handling team.Philips received a complaint regarding the efficia dfm100, which indicated a hardware error log with therapy supply voltage out of range.The device was not in clinical use at the time the issue was discovered.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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