It was reported to philips that the device needed a replacement display.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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The fse evaluated the device on site.It was determined that this was a malfunction of the dfm100 display assy 1.1*, p/n : 453564587191, which was replaced, and the device was returned to full functionality.The device remains at the customer site and no further evaluation is warranted at this time.Based on the information available and the testing conducted, the cause of the reported problem was a malfunction of the dfm100 display assy 1.1*, p/n : 453564587191.The reported problem was confirmed.The customer replaced the ddfm100 display assy 1.1*, p/n : 453564587191 to resolve the issue.
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