FDA Issues Recall of VentStar Oxylog 3000 Medical Device

The U.S. Food and Drug Administration (FDA) has issued a recall of pediatric medical device “VentStar Oxylog 3000,” citing potential leakage in the valve.  Manufactured by Dräger, the VentStar Oxylog 3000 is a pediatric patient breathing circuit, which is designed to be used with Dräger Oxylog 3000 and Dräger Oxylog 3000 Plus Emergency Transport Ventilators.  Read on to learn more about the recall and the possible dangers of this defective medical device.

If you have experienced adverse events from this or a similar medical device, contact the medical malpractice attorneys at MedMalFirm.com to learn more.

FDA Recall Report Information

According to the FDA report, the recalled pediatric medical device may leak around the circuit.  This leakage could result in the patient being forced to re-breathe exhaled gas, which contains reduced levels of oxygen and increased levels of carbon dioxide.  Due to the dangerous nature of the defect, the FDA has classified this recall as a Class I, the most serious designation of recall given by the FDA.  A Class I recall means that there is “reasonable probability” that using the product could result in serious adverse health consequences, including death.

The device is most commonly used in emergency departments, in recovery rooms, and on ambulances.  The breathing circuit is designed to be disposable and easy to transport.  Healthcare providers and consumers who use the VentStar Oxylog 3000 products are urged to check their equipment to make sure they are not actively using the recalled items.  The recall report contains the following identifying information:

• VentStar Oxylog 3000 Disposable Pediatric Patient Circuit
• Dates of Manufacturing and Distribution: May 2013 to March 2016
• Catalog Number: 5704964
• Total units recalled: 1,530 across 26 states including Texas, Florida, New York, California, Tennessee, and Washington.

The recall does not include the Oxylog 3000 ventilator unit.

Medical Malpractice Attorneys Discuss Dangers of Recalled Medical Device

The primary dangers associated with the VentStar Oxylog 3000 include re-breathing exhaled gas, which can cause serious medical conditions, including:

• Hypercapnia – Excessive carbon dioxide levels in the bloodstream. Hypercapnia can cause respiratory distress, damage to the central nervous system, potential for permanent respiratory damage, and death in severe cases.  When carbon dioxide replaces or exceeds healthy oxygen content levels, the patient can actually suffocate due to lack of oxygen, resulting in permanent brain damage or death.
• Hypercarbia/Acidosis – Increased blood acidity levels. Acidosis occurs when the body’s PH levels become excessively acidic resulting in cardiovascular problems.  Acidosis can cause low blood pressure, cardiac arrhythmia, and impaired cardiac functions.  Acidosis can also cause damage to your nerves, hallucinations or delirium, seizures, and death.

Anyone experiencing an adverse medical event related to use of a recalled product, including healthcare providers and patients, is urged to seek medical attention and report their experience to the FDA’s MedWatch Reporting Program.

Understanding Your Rights as a Patient

Manufacturers of medical products are required to monitor their products and report any adverse events that may occur.  Further, they are urged to work with the FDA to warn consumers and healthcare providers if a product is found to be defective.  Similarly, healthcare providers have the responsibility of ensuring that you receive only the highest quality, safe, and appropriate care.  Part of that responsibility includes informing you of any dangers related to medical devices, staying abreast of current recalls or warnings, reporting adverse events, and not using products deemed dangerous or defective.

The responsibilities of healthcare providers are known as their duty of care, or the standard of care.  In Texas, the standard of care refers to medically accepted methods of diagnosis and treatment that other healthcare professionals in the state would provide to a similar patient in a similar situation.  If the healthcare provider breaches that duty of care, he or she may be guilty of medical malpractice.

Getting Help after a Defective Medical Device Injury

As a patient, you have the right to question medical care you have been provided if you believe you have been harmed due to a negligent healthcare provider, a defective medical device, or intentional wrongdoing.  Texas medical malpractice laws offer specific protections for patients, including the right to file a medical malpractice lawsuit if certain conditions are met.  You should know that it is your responsibility as a patient to prove that a manufacturer or healthcare provider breached his or her duty of care.  To do so, you will need the guidance of an attorney who specializes in medical malpractice cases and who can manage the various processes that such cases require.

At MedMalFirm.com, our medical malpractice attorneys understand that the cases we manage are as unique as our clients.  We take an individualized approach to every case, and offer every client guidance that applies directly to them and their best interests.  Our attorneys have successfully litigated medical malpractice cases including defective medical devices, hospital negligence, nursing home abuse, birth injuries, bedsores, and medical and surgical errors.  Our staff is confident that we can help you protect your rights and pursue justice.

To learn more about your rights, Texas medical malpractice laws, or to schedule a free consultation, contact MedMalFirm.com today.  Call us toll free at 877-887-4850, or fill out our online form to get started.