FDA classifies COVID ventilator recall as deadly

The Food and Drug Administration (FDA) Monday classified the recent recall of 73,000 Philips ventilators as Class 1, which means it can cause injury or death, according to Reuters.

Philips received 542 complaints about its respiratory machines with at least one reported death and two injuries. The Trilogy Evo, Trilogy Evo Universal, Evo O2, and EV300 respirators have been found to absorb dirt and dust which can constrict the amount of oxygen being delivered to a patient.

These machines were used in hospital settings for COVID-19 patients. President Donald Trump came under heavy criticism early in the pandemic after signing a contract with Philips for 43,000 Trilogy EV300 ventilators at $15,000 a piece. Critics said Trump allowed Philips to drag its feet in delivering the machines and slammed the administration for not negotiating with the company on price.

The recall follows several others in the last two years. In April 2021 Philips began recalling millions of its BiPAP and CPAP ventilators for a similar reason: sound abatement foam included in the machines was breaking down and being absorbed into the breathing tubes. Complaints had started trickling in in 2011 but there had been no reports of injury or death.

After April 2021, however, Philips received at least 385 reports of ventilator-related deaths, and 105,000 complaints.

Then, in August 2021, the FDA announced a second serious recall, this time for thousands of Philips V60 Plus ventilators.

In September 2022, Philips settled with the Justice Department for $24.8 million over allegations that the company was giving kickbacks to durable medical equipment (DME) suppliers.

Outrage over the faulty respirators has been exacerbated by the fact that hospitals aggressively ventilated patients throughout the pandemic. Hospitals received a Medicare incentive of $30,000–$40,000 for each ventilated patient. 

Some physicians like Dr. Cameron Kyle-Sidell began warning early on that ventilators were likely doing more harm to patients:

The 39-year-old ICU- and ER-trained doctor was beginning to have serious doubts about the manner in which caregivers were intubating people with Covid-19. Reports he’d seen from Italy were indicating as many as 80% of people placed on ventilators had died. Ventilators at his hospital didn’t seem to help his patients as much as he expected. Often, people would get worse after being placed on the machines.