It was reported to philips that the device had a front panel button failure.There was no reported 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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Fse onsite checked and confirmed therapy pcba and processor pcba and ui pca failure, need be replaced.Fse replaced 453564489071 dfm100 assy processor, 453564489061 dfm100 assy therapy and 453564587201 dfm1 assy ui module to solve the issue.The device was operational after repairs were completed.The investigation concludes that no further action is required at this time.
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