Merge hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.Merge healthcare received reports of hemomonitor application crashes with the following error - "hemomonitor.Exe has stopped working unexpectedly" being displayed on the desktop.This error does not restart the computer, since no keyboard and mouse are available the customers have had to restart via the front panel power button.This event did not result in a serious injury to the patient.This error may impact the physician's ability to continue vitals monitoring during cath procedures.(b)(4).
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