Defective Medical Device

FDA Announces Recall of Ventilators Due to Software Problem

by | February 3rd, 2014

February 3, 2014

Manufacturers of the medical devices Americans use on a daily basis are required by law to ensure the safety and integrity of the products they release to the market. Failure to do so can result in patients being harmed, which can lead to costly recalls being implemented. The Norfolk Product Liability Attorneys with Lowell “The Hammer” Stanley explain such a recall was launched due to a malfunction with the software that runs the Covidien Puritan Bennett 840 Series Ventilator.

According to an article from QMed, the recall affects the units that were manufactured April 30, 1998 and March 12, 2010. Reports indicate the affected units have a glitch in the software that can lead to the unit forcing users to breathe on their own. In the event of an emergency, such a failure could result in a patient being seriously harmed, and possibly dying.

Those who are in possession of the affected units have been instructed to contact the manufacturer in order to have their unit serviced with a software upgrade at no cost. Anyone who has been harmed by an affected product should report the incident to the U.S. Food and Drug Administration.

The Norfolk Personal Injury Lawyers with Lowell Stanley would also urge anyone who has been harmed by a defective medical device to hammer the manufacturer with a lawsuit in order to hold them accountable for their negligence. Call us today for a free consultation of your case!

FDA Announces Recall of Defective Medical Devices

by | June 17th, 2013

June 17, 2013

Symbios Medical Products has partnered with the U.S. Food and Drug Administration to initiate a voluntary recall of the company’s GOBlock™ and GOPump™ Rapid Recovery System kits. The recall is being implemented due to several reports that deem the device a Defective Medical Product that could cause serious harm to users.

The faulty devices were manufactured before July 2012, but were distributed to patients between April 1, 2011, and April 30, 2013. The pumps are used to administer medications to patients suffering from numerous conditions.

An FDA Press Release explains the problem with the devices was discovered when the company received five reports claiming the unit had an excessive flow rate for medications. Such a high flow rate could result in a patient suffering from a number of adverse health events, including:

  • toxic medication levels,
  • seizures,
  • heart dysrhythmias,
  • and even death.

While no reports of fatal events have been made, two patients claimed to have suffered serious injuries associated with the use of the defective products.

Those who are in possession of the affected products have been instructed to contact the manufacturer regarding any questions or concerns.

The Norfolk Personal Injury Lawyers with Lowell “The Hammer” Stanley acknowledge the risks associated with the use of a defective medical device. The firm may be able to help if you or a loved one has been hurt by such a product.