Philips received a complaint on the defibrillator indicating that the device had intermittent ecg misrecognition.There was no patient involvement.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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Reporting address line 1:, (b)(6) reporter city: , reporting address state: , reporting address postal: , reporting institution phone:, reporter phone:.A follow up report will be submitted upon completion of the investigation.
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