Two deaths have been reported as a result of potential superbug contamination in endoscopes used at the University Of California Los Angeles Medical Center. Endoscopes are inserted through the throat to examine the body from the inside. A small camera is on the end of medical-grade flexible tubing. Endoscopes are reusable medical devices, requiring a thorough cleaning process following each use. Continue reading “Superbug-Contaminated Endoscope Lawsuit – 2 Deaths Reported”
Covidien Components of Defibrillators May Cause Organ Failure, Strokes or Death
The concern is that devices using Covidien electrodes may delay or fail to activate the electrical shock used to restart the heartbeat of patients during heart attacks, leading to strokes, organ failure or death. Reports of the delay when trying to restart the hearts of two patients resulted in one death. Continue reading “Covidien Defibrillation Electrodes: FDA Class 1 Safety Alert”
The U.S. Supreme Court refuses an appeal from medical device manufacturer Medtronic in a liability lawsuit filed by an Arizona man allegedly left paralyzed by a Medtronic pain pump.
In a related Medtronic matter, Attorney Matt Harman discusses a lawsuit filed on behalf of a mother claiming her daughter died due to a defect and malfunction of her Medtronic insulin pump, prior to the manufacturer providing the FDA with information that later led to a Class 1 recall: Continue reading “VIDEO: Medtronic Pump Lawsuit Advances, U.S. Supreme Court Denies Mfr. Appeal”
Concerns prompt FDA to issue additional safety alert
The FDA issued a “Safety Communication” May 6, 2014 regarding the potential for harm to patients from a small, cage-like medical device implanted in blood veins. The device, the Interior Vena Cava (IVC) filter, is used in patients at risk of developing blood clots or embolisms anywhere in the body, but especially in their legs (which is called deep vein thrombosis). The filter device is an option for patients who cannot take blood thinners. Blood clots and embolisms can travel to heart, lungs, and other organs, causing serious damage or death. Continue reading “FDA: Blood Vein Filters (IVC’s) Could Cause Life Threatening Damage or Death”
Followup to December 2013 Class 1 recall of the HeartWare, Inc. Heartware Ventricular Assist System
In December of last year, the FDA issued its most serious recall, Class 1, for the HeartWare, Inc. “Heartware Ventricular Assist System” pump mechanism. The manufacturer followed up yesterday by reissuing a warning to physicians following additional reports of device failure. Continue reading “Heartware Ventricular Assist System Pump Connector Failure Could Lead to Death: Manufacturer Reissues Warning Following FDA Class 1 Recall Issued”
Trilogy Ventilator power management boards have been recalled due to a failure in the system that could interrupt or stop the mechanical breathing in the continuous or intermittent ventilator support for patients.
The failure in the Philips Brand Trilogy Ventilator could lead to serious injury or death. Continue reading “Philips Brand Trilogy Ventilator Recall: Failure Could Cause Serious Injury or Death”
At the 22nd Annual Product Liability Seminar Continuing Legal Education (CLE) of the State Bar of Georgia, attorneys Matt Harman and Eric Fredrickson prepared a session on medical device preemption. Eric Fredrickson presented the information to the assembled attorneys on February 26, 2014.
The key takeaway for plaintiff’s attorneys in medical device cases that call preemption into question was:
Today the FDA issued and posted a Class 1 recall, the most serious, for the Puritan Bennett 840 Series Ventilator by Covidien saying a software glitch may cause the device to stop working, preventing air from reaching patients who may not be able to breathe on their own and causing serious injury or death. Continue reading “Ventilator Recall: FDA Says Puritan Bennett by Covidien May Stop, Causing Patient Injury or Death”
The FDA has republished a Class 1 recall, the most serious, for the Hospira Inc. GemStar Infusion System.
The GemStar pump by Hospira is designed to deliver fluids via IV, to lower back or spinal areas, and in other parts of the body. It is small, lightweight and can be portable when using battery power. Designed for use in the hospital, home, or other settings, the electronic infusion system can deliver medications, nutrition, and blood or blood products. Continue reading “Class 1 Recall: Hospira Inc., GemStar Infusion System”
The FDA has classified the Medtronic cardiac “guidewires” recall as a Class 1, the most serious category.
Medtronic issued a voluntary recall of the “guidewires,” the wire connectors used to connect cardiac devices that help regulate heartbeat and other functions and facilitate heart surgery because the coating on the wire may disintegrate causing the wire to detach and put the patient at risk for injury or death. Continue reading “Recall of Medtronic Cardiac “Guidewires””