It was reported to philips that the device was detected to be defective.The inspection revealed that the battery of the system was defective as they completed the service life.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 remote service engineer (rse) and with an investigation documented by philips complaint handling.Philips received a complaint on the efficia dfm100 defibrillator indicating that device battery is defective.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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