Dangerous Respiratory Monitor Battery Packs Recalled
By: Cohen, Placitella & Roth @ Jul 13, 2016
A Class I recall is the most serious recall type, reserved only for products that are defective enough to result in serious injury or death.
In mid-2016, the United States Food & Drug Administration (FDA) published a medical device recall notice identifying Medtronic Respiratory and Monitoring Solutions’ battery pack, which is used on patient monitors, in a Class I recall. The battery packs were recalled due to a defect that can lead to fire.
The Details of the Recall
According to the FDA recall notice, cited above, the specific battery packs that are being recalled are those that:
- Are used on Capnostream™ 20 and 20p monitors;
- Are model numbers 016400 and 010520; and
- Were manufactured or/and distributed between April 2014 and February 2016.
The FDA further reports that there are currently a total of 9,817 battery packs that are being recalled in the United States.
The Dangerous Defect
The battery packs are being recalled because of a manufacturing defect found within the packs that can cause them to heat up excessively, leading to fire within the systems’ monitors. The FDA reports that the use of the affected products can lead to serious health consequences, including death.
What to Do If You Use a Patient Monitor
The defect may affect both patients who are being monitored using a Capnostream™ monitor, as well as healthcare providers using the monitors. If you are a healthcare professional, it is essential that you check the monitor’s make and model promptly. If you are using a model that is being powered by a recalled battery pack, you should identify and remove the battery pack immediately. You should then complete the receipt form by email, and a new and defect-free battery pack will be sent to you free of charge. If you have questions, you can also contact Medtronic Respiratory & Monitoring Solutions at 1-800-635-5267.
When Defects Lead to Harm
When a product defect leads to significant injury or death, affected victims have the right to pursue a product liability action against the product’s manufacturer. A product liability lawsuit alleges that the manufacturer breached its duty to design or manufacture a product that was safe for consumer use; that the company manufactured a dangerous device; and that harm (of the plaintiff) would not have occurred but for the defect. A lawsuit can yield compensation for medicals bills, pain and suffering, funeral and burial expenses, and other economic and noneconomic expenses.
Contact an Attorney You Can Trust
If you have been harmed as a result of a defective medical device, our experienced Pennsylvania and New Jersey product liability attorneys can help. With more than four decades of experience advocating for the victims of dangerous medical devices, we know what it takes to recover compensation that clients deserve.
If you think that you may have a lawsuit, do not hesitate to contact us. We will work hard on your behalf, and guide you through everything you need to know about proving negligence. Call us today at 215-567-3500.