If the patient shows either ventricular fibrillation (VF: disorganized/chaotic heart rate) or ventricular tachycardia (VT: unusually rapid heart rate), the AED provides electrical therapy which stops the arrhythmia, and allows the heart to establish a regular rhythm. If the rhythm of the heart is not restored within three to five minutes, VF and VT can rapidly lead to irreversible brain damage and death. For every minute that a patient cardiac arrest goes without being successfully treated with defibrillation, their chance of survival decreases by 10 percent. Some studies have shown that early defibrillation may be an important factor in determining survival after a heart attack.
This week, the U.S. Food and Drug Administration (FDA) announced that it has concerns about the effectiveness and safety of many AED devices. The agency says it has received 28,000 reports of AED malfunctions in the last five years. In 700 of these cases, the malfunctioning led to the patient’s wrongful death because the patient could not receive life-saving defibrillation in time.
The FDA says it is working with many AED manufacturers to improve the safety,design and control of the devices. From January 1, 2005, to July, 10, 2010, 68 separate recalls of AED machines were ordered by the FDA. These AEDs were manufactured by and sold by Cardiac Science, Philips Healthcare, Medtronic, Defibtech, Burdick and GE.
FDA Defective Medical Device Recalls in 2010 include:
• Physio-Control Inc., LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors
• Defibtech LLC, DBP-2800 Battery Pack for ReviveR AED™ and Lifeline AED® Semi-automatic External Defibrillators
• Cardiac Science Corporation, Powerheart, CardioVive, Nihon Kohden, and GE Responder Automated External Defibrillators
• Physio-Control Inc., LIFEPAK 15 Monitor/Defibrillator
Have You Or A Loved One Been Injured By A Defective Medical Device?
If you or a loved one has been injured by a defective medical device you need to speak with an experienced defective medical device attorney as soon as possible. Please contact us online or call our Kansas City office directly at 816.471.5111 to schedule your free consultation.