Philips recalls ventilators manufactured from 2009 to 2021, resulting in 561 suspected related deaths and compensation amounting to more than 70 billion yen
It has been discovered that a Philips ventilator used for CPAP (continuous positive airway pressure) therapy for sleep apnea syndrome has a defect in which the internal polyurethane foam can peel off and be inhaled or swallowed by the user of the device. Philips is recalling millions of units, but so far there have been 561 reports of deaths suspected to be related.
UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication | FDA
Philips Kept Complaints About Dangerous CPAP Machines Secret While Company Profits Soared — ProPublica
FDA says 561 deaths tied to recalled Philips sleep apnea machines - CBS News
https://www.cbsnews.com/news/fda-sleep-apnea-philips-recall-cpap/
In June 2021, Philips issued a recall on its ventilators due to defects. At the time, the company issued a statement saying it had 'been made aware of the potential severity of the issue and took immediate action.'
Philips Respironics recall notification/field safety notice* announced on June 14, 2021
https://www.documentcloud.org/documents/23990842-rp-faq
However, according to a joint investigation by the nonprofit news site ProPublica and the Pittsburgh Post-Gazette, Philips received more than 3,700 complaints from the U.S. Food and Drug Administration (FDA) in 11 years, but did not respond.
Complaints started appearing in 2010, when Philips changed the device to a quieter design that filled the inside of the device with polyurethane foam, similar to that used in sofas and mattresses.
Immediately after this, reports began to appear such as ``There was dirt inside the machine,'' ``There was dust on it,'' and ``There was strange oil on it.'' As of the end of 2015, there were at least 25 opinions specifically pointing out that the polyurethane foam may be falling apart. Tests conducted in the United States revealed that the polyurethane foam used contained formaldehyde, which has been linked to respiratory diseases and cancer.
Additionally, when a medical device may have contributed to patient death or serious injury, or caused malfunction, device manufacturers are required to submit a Medical Device Report (MDR) to the FDA. There were 30 MDRs submitted in the 10 years from 2011 to April 2021 for events related to 'deterioration of polyurethane foam,' and there were no reports of patient death or injury in any of them.
Meanwhile, the FDA received more than 116,000 MDRs from April 2021 to September 2023, of which there were 561 reports of deaths suspected to be related to 'deterioration or breakage of polyurethane foam.' thing.
ProPublica and the Pittsburgh Post-Gazette point out that Philips' delay in responding was due to the high revenue generated by the equipment.
As a result of the delayed recall, the number of ventilators shipped with problems is estimated to be in the millions across most of the United States and dozens of countries.
A class action lawsuit was filed regarding this recall, and a settlement was reached in September 2023, making it possible to claim for financial losses related to the purchase, lease, or rental of the recalled equipment. Specifically, there are three points below.
・Cost compensation of $10,000 (approximately 1.49 million yen) for each recalled device purchased, leased, or rented.
・Equipment return compensation fee of $100 (approximately 14,900 yen) for each recalled device returned by August 9, 2024
・Actual equipment replacement costs required to purchase equivalent equipment to replace recalled equipment from June 14, 2021 to September 7, 2023
Phillips is set to pay at least $479 million (about 71.1 billion yen).
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in Hardware, Posted by logc_nt