Cardiology Product Guide » Defibrillator

Medtronic Fixing Defibrillator For Battery Issue

admin — Wed, 14 Jul 2010 19:24:52 +0000

Medtronic Inc.’s Physio-Control subsidiary said that it has launched a field correction effort to fix certain devices used to shock patients in cardiac arrest because it found a potential battery-power problem, and that one patient may have died as a result. The FDA said nearly 43,000 Lifepak 20 and Lifepak 20e defibrillator/monitors are at issue worldwide.

Read the full story here.

FDA Issues Class I Recall for Physio-Control’s LifePak 20/20e Defibrillators

admin — Wed, 07 Jul 2010 18:46:57 +0000

The Food & Drug Administration has slapped Medtronic Inc’s subsidiary Physio-Control Inc. with a Class I recall of its LifePak 20/20e defibrillators after the company declared a “field correction” for a battery problem last week. Physio-Control issued a “field correction” on July 2, after discovering that some of the devices might lose battery power while in operation.

Portable Defibrillator Helps Police Officer To Save A Bellevue School Teacher

admin — Fri, 11 Jun 2010 20:11:17 +0000

A middle-school teacher was revived after collapsing when a police officer at a Bellevue school on another call helped deploy a defibrillator. As part of a pilot program to improve heart attack survival rates, Bellevue and Kent police officers were issued portable automatic electronic defibrillators and trained in their use in March.

FDA Urgently Recalls AED Battery

admin — Fri, 11 Jun 2010 20:06:04 +0000

The maker of a battery pack used in automated external defibrillators (AEDs) voluntarily recalled more than 5,000 of its units due to potentially fatal errors it causes in devices charged with the battery. The FDA has labeled the recall class I, reflecting the most severe warning and meaning that the affected device has a high probability of causing serious adverse events or death with use.

New use of Boston Scientific devices backed by FDA

admin — Wed, 24 Mar 2010 17:12:51 +0000

A Food and Drug Administration panel unanimously voted for broader use of Boston Scientific’s cardiac resynchronization therapy defibrillators, or CRT-Ds, for patients with heart failure who have no symptoms or only mild symptoms.

CRT-Ds are approved now for treating the most advanced stages of heart failure, but a Boston Scientific study showed they could also benefit healthier patients.

However, the panel said that the use of the devices should only pertain to patients who have a heart problem that causes the left ventricle to contract later than the right ventricle.

For the full story, click here.

Medtronic gets FDA warning letter after inspection

admin — Tue, 08 Dec 2009 15:24:28 +0000

Medtronic Inc has confirmed that it had received a warning letter from U.S. health regulators calling for corrective actions based on an inspection of its Mounds View, Minnesota, facility, the headquarters of its cardiac rhythm management (CRM) business, the company’s largest unit. The letter from the Food and Drug Administration comes in the wake of problems Medtronic has had with its leads that are used with implantable cardioverter defibrillators, known as ICDs.

FDA announces recall of Philips defibrillators

admin — Tue, 13 Oct 2009 05:30:38 +0000

The FDA announced that roughly 5,400 HeartStart FR2+ automated external defibrillators made by Philips have been recalled because they may carry a defective memory chip that can render the life-saving devices inoperable. Although there have been reports of the memory chips in some of the defibrillators failing during routine self tests, none of them have failed during emergencies and caused patient injuries or deaths.

Zoll Medical receives the FDA approval for new LifeVest model

admin — Tue, 15 Sep 2009 04:34:37 +0000

Zoll Medical Corp received the FDA marketing approval for a new model of its LifeVest wearable defibrillator. The LifeVest is worn by patients who are at a risk of sudden cardiac arrest. Zoll said more than 2,000 patients are currently using the product. The company aims to increase its inventory to support further growth.

FDA authorizes Physio-Control to market LIFEPAK 20e defibrillator

admin — Fri, 10 Oct 2008 05:16:44 +0000

The U.S. Food and Drug Administration has granted clearance to Physio-Control, Inc. for the commercialization of LIFEPAK 20e defibrillator/monitor in the United States. The device is an enhancement of the LIFEPAK 20. The new features include a stronger (Lithium-ion) battery and an on-screen fuel gauge. The novel version, also, is designed to facilitate easy transportation. This will help the hospitals to meet the standards set by Joint Commission for Accreditation of Healthcare Organizations to ensure the availability of resuscitation services in all the areas.

Sunshine Heart C-Pulse implantable heart assist device passes 5-year durability testing

admin — Thu, 07 Aug 2008 18:15:58 +0000

The Polymer Technology Group (PTG) indicated that its customer, Sunshine Heart Inc., has passed the five-year milestone on durability-testing of its C-Pulse implantable heart assist device. C-Pulse is designed to be a non-blood-contacting heart assist therapy for treating patients with moderate to severe heart failure, a condition in which the heart progressively loses its ability to efficiently pump blood throughout the body. C-Pulse includes two polymers from PTG.