Philips Encounters Fresh Class I FDA Recall for Evo Respirators
Philips’ Respironics division has grappled with numerous recalls after initially identifying issues with the sound-dampening foam utilized in several of their sleep apnea devices and ventilators in 2021. The Evo ventilator, employed in hospital and professional healthcare environments, is now confronting its second Class I recall within a few months.
The recall was initiated by the Dutch device producer on May 1, instructing users to modify filters more frequently to avoid potential device malfunctions. Earlier, Philips had stated filter use was optional.
Philips’ Trilogy Evo ventilators, which are part of the latest recall, were previously highlighted by Philips in March due to a separate sensor issue, and in late 2021 concerning the soundproofing foam. The company also issued a recall for its V60 respirators in January.
The FDA has noted that Philips is actively investigating the cause of the most recent issue.
Philips representative, Mario Fante, mentioned in an email that Philips Respironics informed the FDA in April of a possible issue with the Trilogy Evo ventilator range. He stated that “prolonged exposure of these devices to environmental contamination could impact the device’s air path.”
The issue could potentially affect around 120,000 devices globally.
Philips has reported that it has manufactured over 98% of the replacement devices and repair kits needed for the largest recall involving CPAP and BiPAP machines. The company has already repaired and returned over 2.3 million devices to consumers and distributors.
Information on Filing a Product Liability Lawsuit
Product liability refers to a manufacturer or seller being held liable for placing a defective product into the hands of a consumer. When it comes to a product liability lawsuit concerning a recalled product such as the Philips Evo ventilator, it is essential to understand the qualifications required to file such a lawsuit.
Firstly, there must be proof of injury or harm. One can only file a product liability lawsuit if they or a loved one have been physically injured or suffered other forms of harm (such as monetary loss due to medical bills or loss of income) due to the defective product. In this case, if you or a loved one has suffered injuries or death due to the malfunctioning of a Philips Evo ventilator, you may be entitled to file a lawsuit.
Secondly, the injury must have been caused by the product defect. The defective product must be the direct cause of your injury. This means that the malfunction of the Evo ventilator, such as its airflow sensor problem, must have directly caused harm to you or your loved one.
Thirdly, you must have been using the product as it was intended to be used. For a product liability claim to be valid, the product should have been used in a way that the manufacturer intended, or the manufacturer must anticipate the product to be used in that way. Therefore, if the Evo ventilator was used in a hospital setting and you or your loved one were injured, you may qualify to file a lawsuit.
Fourthly, the product must not have been substantially changed from the condition in which it was originally sold. If the ventilator has been modified in a way that affects its performance and this modification is a factor in the injury, then it may impact the ability to file a product liability lawsuit.
Finally, remember to keep the product. It is essential to keep the defective product as it may serve as vital evidence in your lawsuit. Your attorney will need to examine it in order to establish your case effectively.
If you or a loved one have suffered injury or even death due to the malfunctioning of a Philips Evo ventilator, you may have grounds to file a product liability lawsuit. It is advisable to seek legal advice to navigate through the process and ensure your rights are adequately represented.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
Were you or a loved one harmed by a dangerous medical device? Parker Waichman LLP helps families recover monetary compensation for harm caused by dangerous products. For your free consultation, contact our national product liability law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
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