Philips Respironics Issues Recall for Ventilators Due to Contamination Risk
Philips Respironics has announced a major recall for several of their ventilator models, namely Trilogy Evo, Trilogy Evo O2, Trilogy EV300, and Trilogy Evo Universal, after discovering contamination risks that could reduce airflow to patients.
The U.S. Food and Drug Administration (FDA) has classified this as a Class I recall, which is the most severe form, indicating that using these devices may lead to significant injuries or even death.
Details of the Recalled Products:
- Names: Philips Respironics Trilogy Evo, Trilogy Evo O2, Trilogy EV300, and Trilogy Evo Universal
- Distribution Dates: March 26, 2019, to March 22, 2023
- Number of Devices Recalled in the U.S.: 73,000
These ventilators provide continuous and intermittent positive airway pressure support for individuals requiring mechanical ventilation. The devices are designed for patients from pediatric age, weighing a minimum of 2.5 kg, to adults. They are commonly found in medical facilities but also in homes for those needing consistent ventilation support.
The Underlying Issue:
The recall was initiated after Philips detected environmental contaminants like dust and dirt in the air pathways of some devices. Over time, such contaminants can accumulate, potentially obstructing the air vents. This can disrupt the ventilator’s ability to deliver the correct air pressure or volume.
Inadequate breathing support can lead to patients experiencing hypoventilation – a lack of oxygen – and an accumulation of harmful gases, leading to grave injuries or death. As of now, Philips has received 542 reports concerning this issue, which includes two injury cases and one unfortunate death.
Who Should Be Concerned?
- Patients dependent on the aforementioned Philips Respironics machines for breathing support.
- Healthcare professionals and at-home caregivers caring for patients using these ventilators.
Safety Measures and Recommendations:
On April 17, 2023, Philips issued an Important Product Notice highlighting:
- Identification: Check the part number located underneath the device and compare it to the listed numbers in the notice.
- Preventative Steps:
- Employ the Philips-approved particulate filter to minimize the risk of airborne contaminants entering the machine.
- Replace filters as instructed.
- Ensure the setting of suitable alarms.
- If any alarms, especially ones signaling service requirements or device malfunction, sound, follow the necessary steps immediately.
- In cases where the ventilator issue remains unresolved, switch to alternative ventilation methods. Always have backup ventilation equipment available.
For further details, individuals can refer to the Medical Device Recall Database. Healthcare professionals and consumers are also urged to report any adverse reactions or quality issues to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
What is the Claims Process if Harmed By a Philips Respironics Ventilator
If someone believes they’ve been harmed by a Philips Respironics Ventilator, they would typically go through a claims process to potentially recover damages. While our law firm cannot provide a precise procedure for every scenario or jurisdiction in this article, the following is a general outline of the steps involved in the claims process:
- Medical Assessment: Before proceeding with any claim, it’s essential to consult with a medical professional to ascertain the nature and extent of the injury. This consultation will provide evidence to support any claims that the ventilator caused harm.
- Document Collection:
- Collect any relevant medical records related to the injury.
- Gather evidence of the specific Philips Respironics Ventilator model and purchase or rental details.
- Document any correspondence or communication with Philips Respironics or any medical professional regarding the device.
- Engage Legal Representation:
- Consult one of our attorneys who focus their practice in medical device or personal injury claims.
- They can guide you through the complexities of the legal system and ensure you’re taking the right steps.
- Notification: Inform Philips Respironics of your intention to claim, detailing the injury and any other losses. This often involves sending a formal “notice of claim” letter.
- Negotiation: Many companies, including Philips Respironics, might try to settle the matter out of court. Your attorney will negotiate with their legal team to arrive at a fair compensation amount.
- Filing a Lawsuit: If negotiations don’t result in a settlement, your attorney might recommend filing a lawsuit. This step involves:
- Drafting and filing a complaint outlining the legal basis for the claim.
- Engaging in discovery, where both sides exchange evidence and information.
- Possibly attending mediation or settlement conferences to try and resolve the dispute without a trial.
- Going to trial if a settlement isn’t reached.
- FDA Reporting: While it’s primarily the responsibility of healthcare providers, patients can and should also report adverse events related to medical devices to the FDA’s MedWatch Program. This reporting can help the FDA identify and better understand the risks associated with the product.
- Compensation: If successful in your claim, you could be awarded compensation for medical bills, lost wages, pain and suffering, and other damages related to the injury.
Remember, this is a general overview, and the specifics can vary based on local laws, the particulars of the injury, and other individual circumstances. Always consult with a legal professional about your unique situation.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
Parker Waichman LLP helps families recover monetary compensation for harm caused by dangerous products. For your free consultation, contact our national Philips Respironics Lawsuit Law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
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