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The FDA’s complaint-tracking system for medical devices allowed Philips to obscure when it knew about dangerous CPAPs. New reporting shows the regulatory lapses extend to many devices and companies.
The devices at their bedsides were lifelines, until they learned the foam inside could break down and make them sick. Now, they’re plagued by illness, lost sleep and worry.
Tainted CPAP machines and ventilators went to children, the elderly and at least 700,000 veterans despite internal warnings. Company insiders said the devices posed an “unacceptable” risk.
An international team of reporters reviewed thousands of records and interviewed insiders to expose what went wrong in the global corporation.