The FDA issued its second Class I recall in as many weeks to Philips’ sleep and respiratory care division, offering up its most serious classification for a safety issue that could inadvertently lower the oxygen flow rate in certain ventilators.
All of Philips’ ventilators designed to provide high-flow oxygen therapy are affected by the recall, comprising more than 16,500 of the company’s V60 and V60 Plus ventilators distributed from May 2009 until June of this year.
Those devices are used in hospitals for patients in need of mechanical breathing support, including those with respiratory failure, chronic respiratory insufficiency or obstructive sleep apnea.
In June, Philips notified healthcare providers and patients of an issue it had identified in which a partial blockage of the V60 and V60 Plus devices’ breathing circuits could cause the devices to provide a lower oxygen flow than is required, potentially resulting in serious adverse events or even death.
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At the core of the issue is a safety mechanism in the ventilators that caps the oxygen flow delivered to a patient and issues a low-priority alarm when the system reaches a default maximum pressure limit. A blockage to the flow of oxygen could raise the pressure, therefore triggering the safety cutoff and preventing the device from reaching the necessary level of oxygen flow.
According to the FDA’s recall notice, a total of 61 incidents and 25 injuries have been linked to the issue, with no deaths reported.
Rather than recalling the devices in the truest sense of the word—that is, asking all affected healthcare providers to return the ventilators to the company—Philips has instead issued a new set of safety guidelines governing ongoing use of the ventilators.
Hospital staff must conduct “constant and close monitoring” of all patients connected to the ventilators, Philips said, keeping a close watch on their oxygen saturation levels and responding to all alarms immediately, regardless of their priority level.
The company also added further details about the safety mechanism to the ventilators’ user manuals and asked healthcare providers to review the addendum and watch Philips’ e-learning training videos for the ventilators to better understand the potential issue.
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The recall is unrelated to another safety notice issued by Philips earlier this year concerning several of its continuous and noncontinuous ventilators, including CPAP and BiPAP machines to treat sleep apnea.
That recall was also initiated in mid-June and given the FDA’s Class I designation about a month later after an issue arose in which the polyester-based polyurethane foam added to the devices to reduce sound and vibrations could potentially break down over time, causing black debris and other chemicals to flow into the breathing pathway.
The issue has so far resulted in at least 1,200 FDA complaints, with more than 100 injuries linked to the disintegrating foam.
As a result, Philips’ second-quarter earnings report included a drop of about 16% in sales in its connected care division, as well as a €250 million budget provision to account for the costs of the recall. The company said it plans to triple production of replacement units and repair kits for the affected devices by the end of the year.
“We fully understand the impact that this is having on patients, as their well-being is at the heart of everything we do at Philips,” CEO Frans van Houten said at the time. “We are in discussions with the relevant regulatory authorities to obtain authorization to start deploying the repair kits and replacement devices that we are producing.”