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AED 22 articles

Reports of AED failures prompt FDA to toughen approval standards on external defibrillators

The Food and Drug Administration (FDA) is strengthening its approval process for automated external defibrillators (AEDs) in hopes of curbing the outrageously high number of failures in the life saving devices. AEDs are portable devices used to deliver an electric shock to restore normal rhythm in patients experiencing cardiac arrest or heart rhythm problems. They are installed and ready to use in many public places. The devices can save lives if used promptly in emergency situations. But since 2005, the FDA says it has received 72,000 reports of the devices failing. There have also been numerous recalls of AEDs in ... Read More

Urgent device correction issued on Heart Sync defibrillators

Just days after the Food and Drug Administration (FDA) announced the worldwide Urgent Device Correction involving CONMED automatic external defibrillators (AED), the agency alerted the public to a similar issue with Heart Sync Inc. devices. AEDs are lifesaving devices used by trained individuals to send a therapeutic jolt of electrical energy to the heart to treat heart rhythm abnormalities and cardiac arrest. Both the CONMED and Health Sync notices involve defibrillator electrodes errors that could result in a delay of therapy, which could lead to serious health consequences or death to patients. The Heart Sync Urgent Device Correction involves certain Multi-function ... Read More

Defibrillator maker issues Field Safety Alert after incident reports, patient death

Medical device maker Covidien has issued a Field Safety Alert for a defibrillator, involving connector compatability issues involving some types of electrodes with certain automatic external defibrillators (AED). The issue involves Medi-Trace Cadence and Kenall Multi-function Defibrillation Electrodes when used with Phillips FR3 and FRx Defibrillators. Covidien has received two reports where customers attempted to use a Covidien electrode with a Phillips FR3 AED unit. The mismatch of these devices contributed to a delay in resuscitation and may have contributed to the death of another patient. AEDs are portable electronic devices used to treat life-threatening cardiac dysrhythmias, ventricular fibrillation and pulseless ... Read More

Public access defibrillator recalled due to power/battery defect

Another public access cardiac defibrillator model is being recalled by the manufacturer due to a defect that could delay or prevent treatment to a patient during a cardiac event. The recall comes six months after the Food and Drug Administration (FDA) proposed more oversight for makers of emergency external defibrillators due to dozens of recalls of the devices and about 45,000 reports of device failures in the past seven years. Automated external defibrillators (AEDs) are life-saving devices that send a jolt of electric current to the heart of individuals who are unconscious and suffering from cardiac arrest. The jolt is ... Read More

More research needed to determine birth defect risks with SSRIs, AEDs

A review of some of the most commonly used prescription drugs among pregnant women aims to raise awareness and bring more research to potential side effects that may harm developing fetuses. The review was published in a recent issue of the journal Obstetrician & Gynecologist. “Many pregnant women use prescription drugs. However, the risk to the fetus remains unknown,” said Alastair Sutcliffe, Reader in Child Health, ULC Institute of Child Health, and co-author of the study. The most common prescription drugs used among pregnant women include ones that treat hypertension, asthma, epilepsy and depression. For the study, researchers narrowed their ... Read More

Study: Cardiac defibrillators not widely used, and often fail

Automated External Defibrillators, or AEDs, used to shock the heart of someone in cardiac arrest, can be found in many public places. They are designed to be readily available in order to save lives. But a new study presented this month at the annual meeting of the Society for Academic Emergency Medicine in Chicago shows that if the devices are to serve the purpose for which they were made, people must use them – and fast. Unfortunately, they are rarely used. And when they are put to use, they often fail. When a person experiences cardiac arrest, a shock from an ... Read More

Study: Up to one-third of all birth defects caused by prescription drugs

As many as a third of all birth defects are caused by prescription drugs, according to a review published in the journal The Obstetrician & Gynecologist. Congenital abnormalities affect an estimated 2 to 3 percent of all births, and about 1 percent of those are thought to be caused by prescription drug use during pregnancy, according to the study’s authors. While many pregnant women use prescription drugs to treat infections or chronic conditions, it is often unknown just how dangerous those drugs can be to developing fetuses. Researchers focused much of their attention to two particular types drugs – antidepressants and anti-epileptic ... Read More

Anti-epileptic drugs can prevent migraines but may be dangerous to fetuses

A daily dose of anti-seizure drugs, including Topamax and Depakote, can help prevent recurrent migraine headaches, according to new preventative guidelines from the American Academy of Neurology. Researchers studied a once-daily dose of Topamax (topiramate) on patients who suffer from regular migraines and found that the medication decreased the frequency and often the severity of migraines by about 50 percent. The guidelines say that other preventative measures include certain beta-blockers, herbal products, and over-the-counter anti-inflammatories including ibuprofen and naproxen. Researchers speculate that the medications dampen the brain’s ability to generate the pain associated with the headache. Treating frequent migraines is ... Read More

Lawsuit claims Depakote during pregnancy caused serious birth defect

A mother has filed a lawsuit against the makers of the anti-seizure medication Depakote claiming that using the drug while she was pregnant caused her son to be born with a penile birth defect. The lawsuit claims that Abbott Laboratories knew the drug was dangerous to developing fetuses, but failed to adequately warn of the potential side effects when used by pregnant mothers. The defendant’s son was born in April 2010 with a birth defect known as hypospadias. Hypospadia is a birth defect in which the opening of the urethra develops on the underside of the penis. In severe cases, ... Read More

Defibrillator recall reinforces need for tougher quality standards

A nationwide recall is underway for a type of automated external defibrillator (AED) manufactured by Cardiac Science. The device, designed to resuscitate patients who are in cardiac arrest, has a defect that may cause it not to deliver adequate defibrillator therapy, which could lead to serious injury or death. This recall is listed as a Class 1, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products may cause serious adverse health consequences or death. AEDs by various manufacturers have been plagued by defects over the years, ... Read More