In addition, the submission of the medical device report is required of device manufacturers by 21 cfr 803. Neither the submission of information by a manufacturer pursuant to this rule nor public release of such information, constitutes an admission that a device has malfunctioned or establishes the existence of any connection between a-product any any death or injury. The information in the medical device report is based primarily on information related by third party sources; the accuracy of their reports and veracity of the sources have not been confirmed by the reporting party. Any business information contained in this report, such as sales and production figures, are confidential information and should be treated as such.

During the surgical procedure, the hospital experienced a number of power outages (due to thunderstorms). When the power was restored after one of the outages, the suction pump reportedly restarted itself in reverse. The perfusionist then stopped the suction pump. The hospital lost power two more times after this incident. This event did not repeat itself during the subsequent power outages. No patient injury has been reported as a result of this incident.