The incident happened in February, 2016 and luckily for the patient, the doctors patiently waited for the PC to reboot after the scan was done, instead of panicking. Merge Hemo is often used by heart surgeons to supervise heart catheterization procedures, during which doctors insert a catheter inside veins and arteries in order to diagnose various types of heart diseases. Merge Hemo consists of two main modules. The main component is the actual medical device, connected to the catheters, through which data acquisition takes place. This component is connected to a local PC or tablets via a serial port. The second component is a software package that runs on the doctor’s computer or tablet and takes recorded data and logs it or displays it on the screen via simple-to-read charts. However, the Merge Hemo PC app may crash like any normal software does but being an specialised equipment, the doctors report the event. The software vendor must then investigate and file an Adverse Event Report with the FDA (US Food and Drug Administration). As reported above, this case is based on one such report filed by Merge Healthcare in February. The report states that Merge Hemo suffered a mysterious crash right in the middle of a heart procedure when the screen went black and doctors had to reboot their computer. Fortunately, the patient was sedated, and the doctors had five minutes at their disposal to wait for the computer to finish rebooting, start the Merge Hemo application again, and complete their procedure without any health risks for the patient. Based on the report by doctors, Merge investigated and found that the crash was attributed to the antivirus software running on the doctors’ computer. The report says that the antivirus was configured to scan for viruses every hour, and the scan started right in the middle of the procedure, crashing Merge Hemo and risking a patient’s life. Merge says the antivirus froze access to crucial data acquired during the heart catheterization. Unable to access real-time data, the app crashed spectacularly. The company said that their documentation provides instructions for the medical authorities to whitelist Merge Hemo’s folders in order to prevent anti-virus software from scanning it during such difficult procedures. However, the medical staff disregarded the documentation in this case and the resultant crash would have risked the patient’s life.
