After it received several reports of serious and fatal injuries, the Food and Drug Administration (FDA) ordered an immediate recall of Philips Respironics V60 and V60 Plus Ventilators.
Hospitals often use these ventilators for patients who cannot breathe on their own, have chronic breathing problems, or suffer from severe sleep apnea. An unexplained power fluctuation could cause a ventilator to shut down without warning and without triggering an alarm.
“Such failures may lead to patients being deprived of oxygen for an extended time, which could cause serious adverse health consequences and death,” the agency reported.
The recall notice included instructions on how to safely operate the ventilators until the company could repair them.
Philips CPAP Machines
Power fluctuation is a new problem that the troubled company must immediately deal with.
Power fluctuation could be a design defect or a manufacturing defect. We don’t know which one yet. We do know that the company is strictly liable for injuries, regardless of the nature of the defect.
The same things apply to the well-chronicled issues with polyurethane foam in continuous positive airway pressure machines.
Philips designers added a foam layer to their CPAP machines which reduces the motor’s noise.
Due to a design flaw or a manufacturing flaw, the foam breaks up, exposing users to one of the most toxic substances on earth.
“This particular foam may break down and can result in serious injury, which can be life-threatening, cause permanent impairment and/or require medical intervention to prevent permanent injury to users,” the agency said in 2021.
As early as 2018, company officials knew particles from disintegrating polyurethane foam entered the air stream.
But the company did nothing until the FDA forced the company to recall these machines in 2021. More people have been injured over the slow recall than were injured by the dangerous machines.
The company claimed it didn’t issue a recall earlier because it handled the defective machine complaints on a case-by-case basis.
Case-by-case is a good way to handle negligence cases, like car wrecks.
Even seemingly similar collisions involve different facts and different legal theories.
Defective product claims are different. If one or two products have an issue, the rest of them probably have the same problem, since they’re usually made on the same assembly line.
Most of the defective product claims our New York personal injury attorneys handle are failure-to-warn claims.
Philips CPAP machines are a good example. The company knew about the foam breakup problem, and it could have addressed that issue in several different ways.
However, it made no effort to warn consumers about it.
The underlying issue is generally a:
- Manufacturing Defect: These issues are very common in today’s gadgets. Usually, manufacturers combine different components from different parts of the world into one machine, although these components have only been tested in laboratories.
- Design Defect: Simple errors often cause serious injuries in the design phase. If a power source doesn’t generate enough juice to operate the device, one would think engineers would go back to the drawing board.
When companies ignore product dangers and put people at risk to increase their profits, substantial compensation for victims is usually available. Only a very large amount of damages convinces these companies to change the way they do business.
At Napoli Shkolnik PLLC, our New York personal injury lawyers hold companies responsible when they try to sell defective products to unsuspecting consumers. Reach out to us today for a free consultation.