Philips warns users that some ventilators could stop working without warning
The devices could stop working leaving a patient without respiratory assistance
Philips Respironics is warning customers that some of its ventilators may stop working properly, leaving a patient without respiratory assistance.
According to a notice posted Monday by the U.S. Food and Drug Administration (FDA), there is a potential issue with the electrical circuit in the Philips Respironics' V60/V60 Plus and V680 ventilators, which controls the 35V power supply to the ventilator and alarm.
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The electrical circuit issue could cause the device to stop working without setting off an audible or visual alarm to warn the user and "the patient may no longer receive respiratory assistance," the warning notice continued.
The company notified the "relevant competent authorities" in regard to this issue. It also projected that there is "an average of less than one silent shutdown among one million uses per year."
However, the company listed actions that customers need to take in order to "mitigate the rare possibility of the hazard caused by the 35V electric circuit issue."
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If those actions can't be taken "Philips Respironics recommends each institution deliberately make a decision that balances the risks and benefits of continued use of the V60/V60 Plus and V680 against the risks and benefits of ceasing use and/or substituting other ventilators," the notice continued.
This includes considering "the institution’s capabilities and patient needs."
Philips Respironics business leader David Ferguson said in a statement that the "V60 ventilator has been in service for more than 10 years with a high record of reliability."
Any time the company identifies an issue, it is addressed "thoroughly and transparently in consultation with the relevant competent authorities," Ferguson continued.
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The company said it is already addressing the issue and will provide "regular updates to customers on the development of its plan to address the issue."
The notice comes less than a year after the company voluntarily recalled other medical devices due to concerns that a foam component may disintegrate and be inhaled by the user possibly causing health issues including toxic and carcinogenic effects.