How did 45 Russian ventilators linked to deaths in Russia reach U.S. with no FDA oversight?

Who could have imagined that a gift from the Kremlin might need to be examined for safety?

The Kremlin shipped 45 made-in-Russia Aventa-M ventilators to America earlier this year, a model that is now banned in Russia after six people died in hospital fires that reportedly involved the devices.

The Aventa-M ventilators were not approved as safe for use in the U.S. by the F.D.A. before that very same model was sent to New York and New Jersey at the peak of their coronavirus surges, Reuters reports.

Reporting from Marisa Taylor and Gleb Stolyarov at Reuters:

The 45 Aventa-M ventilators were sent to the United States after U.S. President Donald Trump and Russian President Vladimir Putin discussed the shipment in a March 30 phone call. The equipment was received by Federal Emergency Management Agency (FEMA) officers in New York on April 1st.

At the time, officials in New York and New Jersey were bracing for an expected wave of severely ill patients in desperate need of mechanical breathing assistance as the coronavirus attacked their lungs.

The Kremlin and U.S. State Department hailed the delivery as an example of collaboration to fight a common enemy.

To help cope with the fast-spreading COVID-19 pandemic, the U.S. Food and Drug Administration had introduced an emergency protocol to allow ventilators to be distributed without the agency's routine, and more time-consuming, approval process.

Read more at Reuters:
Exclusive: Russian ventilators reached U.S. states without FDA oversight[May 22, 2020 / 10:35 AM /Marisa Taylor, Gleb Stolyarov]

Related:

After Deadly Fires, Russia Suspends Use Of Ventilators It Also Sent To U.S.
[rferl.org]

IMAGE: An Aventa-M ventilator produced at the Urals Instrument-Engineering Plant, TASS