Completed an extraordinary inspection of JSC “Ural instrument engineering plant”, which was organized by Roszdravnadzor after the fire in hospitals of Moscow and St. Petersburg of the ventilator “Aventa-M”.
“In the course of surveillance activities revealed violations of the production processes, as well as the discrepancy of a medical product “the ventilator “Aventa-M” on the other 9444-004-07509215-2010 with accessories” (the registration certificate FSR № 2010/09268 from 19.02.2016) operational and technical documentation”, – stated in the conclusion of experts of Roszdravnadzor.
However, during the examination of quality, efficacy and safety of the ventilator “Aventa-M” not established a direct link between the identified violations and the incident of fire.
Currently, by order of Roszdravnadzor of JSC “Ural instrument plant” carries out corrective actions, including, including review and verification of devices “Aventa-M” in circulation.
Fires in intensive care at a Moscow hospital name and spasokukotsky St George’s hospital in St. Petersburg took place on 9 and 12 may, the victims were a total of 7 patients.