| Developers: | Ural Instrument-Making Plant |
| Last Release Date: | 2020/04/15 |
| Branches: | Pharmaceuticals, Medicine, Healthcare |
Aventa-M is a ventilator.
2024: Passing military tests
The Russian Aventa-M artificial lung ventilation apparatus (IVL), produced by the Radioelectronic Technologies Concern (KRET; included in the state corporation "Rostec"), received positive results of tests of military conditions. The press service of Rostec announced this on January 29, 2024.
The test process involved exposing the apparatus to similar conditions experienced by military vehicles. At first, the Aventa-M was doused with water and dropped from a height of more than 1 meter, as a result of which the cover of the case cracked. The vehicle was then subjected to overloads and vibrations on a vibration stand simulating working conditions inside combat vehicles. After that, the device was frozen to -60 degrees Celsius and then thawed, while the water on its body turned into icicles.
The next step was to heat the body panels with a burner, causing the tarpaulin on which the apparatus stood to catch fire. However, Aventa-M continued to function, providing reliable patient breathing.
The results of the crash test of the ventilator were commented on by Pavel Boltaev, head of the department of resuscitation and anesthesiology of the City Clinical Hospital No. 36 in Yekaterinburg. He said that the number of complications after ventilation when using Russian and imported ventilators is the same, which demonstrates their equal effectiveness in work.
According to the doctor, the used devices produced by market leaders - the United States and Germany - were massively out of order after admission to the hospital due to voltage surges in the first year of operation, after which they were sent for warranty repairs. At the same time, the Russian device withstood a short circuit.
As stated in Rostec, the Aventa-M apparatus is competitive in quality with the best Western models and is successfully used in intensive care units and ambulances. These tests confirmed its high reliability and ability to operate in the most difficult conditions.[1]
2020
The manufacturer of Aventa-M devices violated the law by not notifying Roszdravnadzor of 900 changes in equipment
In November 2020, the Arbitration Court of Yekaterinburg ruled that the Ural Instrument-Making Plant misled Roszdravnadzor by not notifying the department of 900 changes to the design of the Aventa-M artificial lung ventilation apparatus. The last 200 changes are for 2019-2020.
 | The manufacturer, making changes to the design of Aventa-M, did not notify Roszdravnadzor in order to amend the registration dossier of a medical device in the manner established by the Government of the Russian Federation, and also implemented Aventa-M on the territory of the Russian Federation and beyond, which entailed harm to the life and health of citizens, - reported in the materials submitted by Roszdravnadzor. |  |
According to the law, the manufacturer of medical equipment is obliged to report all technical changes to Roszdravnadzor. If they decide that the quality and safety of the device may suffer, the department has the right to appoint an examination - the same as when registering. However, all information about the Aventa-M apparatus remained in the internal documents of the plant.
According to TASS, on October 22, 2020, the operative part of the decision of the Arbitration Court of the Sverdlovsk Region was published, according to which the UPZ was fined 500 thousand rubles under Part 2 of Art. 6.33 of the Code of Administrative Offenses of the Russian Federation ("Sale or import of poor-quality medical devices into the territory of the Russian Federation"). The Ural Instrument-Making Plant filed an appeal against this decision.
The trial began after two Russian hospitals suffered fires that killed several patients. According to the first deputy head of Rostec, Vladimir Artyakov, the fires did not arise due to the design features of the Aventa-M ventilators, due to incorrect approaches to the use of equipment.[2]
A fine of 500 thousand rubles for UPZ for the supply of poor-quality ventilators
The Ural Instrument-Making Plant (UPZ) was fined 500 thousand rubles by the Arbitration Court of the Sverdlovsk Region for supplying poor-quality Aventa-M ventilators. The meeting took place on October 20, 2020. Read more here.
In the United States, 45 Aventa-M ventilators were destroyed after their fire in Russian hospitals
As it became known on October 19, 2020, 45 Aventa-M ventilators were destroyed in the United States after their fire in Russian hospitals. This was reported by the US Emergency Management Agency (FEMA).
According to a representative of the agency, whose words are quoted by BuzzFeed, medical equipment "was actually thrown into the trash... in accordance with strict regulatory requirements for hazardous waste management established by the United States General Services Administration (GSA) and the Environmental Protection Agency (EPA). "
At the same time, it is unclear when exactly the disposal was carried out. BuzzFeed notes that cases with their ignition could have influenced the refusal to use Russian ventilators, as a result of which six people died in hospitals in Moscow and St. Petersburg in May. After the incident, the US authorities placed the devices in warehouses in New York and New Jersey in case the situation with the coronavirus COVID-19 in these states worsens.
Other reasons are also called that prompted the United States to get rid of the Russian Aventa-M devices. Their receipt caused a storm of indignation among Democrats who accused US President Donald Trump of receiving equipment from a company included in the US sanctions lists in 2014. We are talking about the Ural Instrument-Making Plant, which is part of JSC Concern Radioelectronic Technologies (KRET) at Rostec.
The publication says that the Aventa-M ventilators supplied to the United States were distributed between hospitals in New York and New Jersey, but were never used. According to Buzzfeed, it subsequently turned out that the equipment needed adapters to connect to American power grids, and there were no adapters in hospitals. As a result, the systems were never launched in medical institutions.[3]
Allowing the sale of devices after fires in hospitals
On July 22, 2020, it became known that Roszdravnadzor allowed the sale of Aventa-M ventilators after fires in hospitals. The Ural Instrument-Making Plant (UPZ), which produces this medical equipment, has resumed deliveries of new devices.
In addition, as the press service of the Radio Electronic Technologies Concern (KRET) reported, owns the Ural Instrument-Making Plant, UPZ rechecks previously supplied products at the installation sites. Roszdravnadzor issued an updated registration certificate for Aventa M ventilators, added to the KRET.
| | Aventa-M artificial lung ventilation devices according to TU 9444-004-07509215-2010 with accessories can be allowed for use only after additional verification of functional and technical characteristics and receipt of relevant documents, the Roszdravnadzor said in a statement. | |
The department added that by July 22, the Ural Instrument-Making Plant, where these devices are produced, is carrying out "corrective measures" in relation to ventilators.
According to Vademec, in the new version of Aventa-M devices, the components manufactured by the German VBM Medizintehcnic GmbH have changed to components of the Taiwanese company Vadi Medical Technology. In addition, the equipment included solutions from the Irish Covidien (part of Medtronic), the German BluePoint and the Russian RTI Group Silicones.
Earlier, Roszdravnadzor, when checking the UPZ, discovered inconsistencies in mechanical ventilation and technical documentation for them, having seized five batches of devices. At the same time, the department lifted restrictions on the circulation of other devices, not finding a direct connection between violations and fires in medical institutions.
Specialists of the Federal Service for Supervision in the Field of Health did not find a direct connection between shortcomings in the production of ventilators and fires in hospitals in Moscow and St. Petersburg, where these devices were installed.[4]
Increase in the production of devices by 2.6 times
The Ural Instrument-Making Plant (UPZ) in 2019 increased the production of artificial lung ventilation devices by 2.6 times compared to 2018. This is evidenced by the reporting of the company referred to by Interfax. Read more here.
KRET will spend 250 million rubles on the transportation of ventilators recalled after fires
On June 23, 2020, it became known that it would KRET spend 250 million rubles on the transportation of those recalled after the fires artificial lung ventilation devices. " Aventa-M The corresponding tender publication "MBH Media" found on the public procurement portal. More. here
Equipment recall
On June 4, 2020, it became known about the recall of Aventa-M artificial lung ventilation devices (IVL) after fires in hospitals, which, presumably, arose due to a malfunction of this medical equipment. The recall was announced by the interim director of the Ural Instrument-Making Plant, Alexander Morozov, in a letter sent to customers and Roszdravnadzor.
| | In connection with the decision made by the Federal Service for Supervision of Healthcare to suspend the use of Aventa-M ventilators produced after the 01.04.2020, UPZ JSC decided to carry out a mandatory program to additionally check the above devices for functionality and safety. These checks can be carried out both on the territory of the manufacturer and at the place of actual location of the devices, - said in a message referred to by Vademec. | |
The manufacturer promises to return the recalled equipment in full safety and good condition after the inspection. The company also undertakes all expenses related to the maintenance and storage of equipment, its testing and technical research.
On June 5, 2020, Deputy Minister of Health Viktor Fisenko told TASS that checking ventilators after fires in hospitals in Moscow and St. Petersburg could be completed within the next two weeks.
Alexander Morozov, in a letter dedicated to the recall of devices, said that based on the results of additional inspections of ventilators , the results of a technical study carried out, drawn up by an appropriate protocol or entry in the product passport, as well as documents confirming the possibility of circulation of this medical device, will be sent.[5]
Termination of sales in Russia
On May 13, 2020, the Federal Service for Supervision of Healthcare (Roszdravnadzor) announced the blocking of sales of Aventa-M ventilators, due to which, according to preliminary data, fires occurred in two medical institutions in Russia - at the S. I. Spasokukotsky City Clinical Hospital in Moscow (May 9) and St. George's Hospital in St. Petersburg (May 12).
According to the order signed by the head of Roszdravnadzor Alla Samoilova on May 12, 2020, the circulation of equipment manufactured from April 1, 2020 at the Ural Instrument-Making Plant stops.
The use of Aventa-M devices has been suspended "due to the threat of harm to the life and health of citizens during its use," Roszdravnadzor said.[6]
The check will also be carried out by specialists from the Ural Instrument-Making Plant. As stated in the concern KRET (it includes a plant), devices under the Aventa brand have been supplied to hospitals since 2012, they were tested under high load and there were no complaints about their safety.
In addition, Russia sent a batch of Aventa-M devices to the United States. They were received by warehouses in New York and New Jersey, where severe shortages were predicted. On May 13 , 2020, the US authorities announced that they would decide on the use of Russian Aventa-M devices following an investigation into the causes of fires in the hospital.
According to TASS, the cause of the fire in the Moscow hospital, where an elderly woman who was on artificial lung ventilation died, according to preliminary data, was a malfunction of the ventilator. The source of the agency says that the fire in the St. Petersburg hospital began with a ventilator, which "literally broke out." The Governor of St. Petersburg, Alexander Beglov , said that, according to preliminary data, the device caught fire due to a short circuit.
Fire in a hospital in St. Petersburg due to a fire in a ventilator
On the morning of May 12, 2020 St George's Hospital , a St. Petersburg fire broke out in, as a result of which several people died. According to sources, "" Interfax we are talking about six dead. All dead patients were connected artificial lung ventilation devices to the intensive care unit, where those infected with coronavirus were treated. According to COVID-19 preliminary data, the production apparatus Aventa-M of the Ural Instrument-Making Plant caught fire. More. here
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