As noted, “violations of production processes” were identified, as well as a mismatch of the medical device with “operational and technical documentation”.
“At the same time, during the examination of the quality, efficiency and safety of the Aventa-M ventilation apparatus, there was no direct connection between the identified violations and the fires that have occurred,” the message said.
According to the instructions of Roszdravnadzor, the enterprise carries out corrective measures.
On May 9, a patient died as a result of a fire in the Moscow clinical hospital No. 50 named after Spasokukotsky.
A few days later, a fire occurred in the hospital of St. George in St. Petersburg, five people became victims. The leadership of the medical institution stated that it would not use Avent-M mechanical ventilation devices until the investigation was completed.
Later it was decided to suspend the circulation on the territory of Russia of devices manufactured since April 1, 2020.