The Merge Hemo medical device is used to collect data while surgeons insert a catheter inside veins and arteries, and that data is logged and displayed on a computer screen or tablet. In this incident, the device lost connection and crashed when the computer to which it was connected began running its automatic antivirus software.
According to an event report Merge Hemo filed with the FDA, the unnamed Merge Hemo customer was able to eventually reboot the computer after five minutes.
“Based upon the available information, the cause for the reported event was due to the customer not following instructions concerning the installation of the anti-virus software,” according to the event report. “Therefore, there is no indication that the reported event was related to product malfunction or defect.”
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