31 hours ago MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART XL+ DEFIBRILLATOR/MONITOR XL+ DEFIBRILLATOR ... CLIA | TPLC : PHILIPS MEDICAL … >> Go To The Portal
A new study, “Analysis of Automated External Defibrillator (AED) Device Failures Reported to the Food and Drug Administration (FDA),” published online in the Annals of Emergency Medicine, requires attention and careful analysis.
Like other pieces of essential safety equipment, the Philips HeartStart Home Defibrillator was designed to be safe, reliable and easy to use. The Philips HeartStart Home Defibrillator is the first and only defibrillator available without a prescription.
Do I need to perform maintenance my defibrillator? Philips AEDs are self-monitoring. They perform regular self-tests to make sure that everything is working. However, there are 2 parts that need regular replacement—the pads and the battery. The device has reminder lights to help you remember.
WASHINGTON-- More than 1,000 cardiac arrest deaths over 15 years are connected to the failure of automated external defibrillators (AEDs); battery failure accounted for almost one-quarter of the failures.
The DeLuca, et al. study captured a total of 40,787 “AED related events” reported to the FDA over a 15-year period (June 1993-October 2008). Their analysis indicates there were 1,150 “AED related event” reports associated with an unsuccessful resuscitation. Although the term “failure” is used in the title of the study and elsewhere, 39,563 of “AED related events” apparently involved successful resuscitations.
Perhaps the “AED failure” we need to be most concerned about is the failure to widely deploy AEDs wherever they are needed—and to engender their use by bystanders.
A new study, “Analysis of Automated External Defibrillator (A ED) Device Failures Reported to the Food and Drug Administration (FDA),” published online in the Annals of Emergency Medicine, requires attention and careful analysis. [i] It should also serve as a reminder to program coordinators that device maintenance is fundamental to the success of every AED program.
Note: It’s essential to keep AEDs well-maintained, to train anticipated users, to know how to easily locate devices, and to have a well-planned and executed response. For more information, click here .
The annual incidence of out-of-hospital cardiac arrest is about 295,000 and the mean rate of survival to hospital discharge is 8%. [x] If these numbers are extrapolated to calculate incidence and survival rates during the 15-year study period, approximately 4,425,000 people would have suffered SCA and 354,000 people would have survived. If this is true, “AED failures” would have occurred in a fraction of one percent of cases.
Researchers at the Arizona Emergency Medicine Research Center, the University of Arizona Department of Medicine, and the Christus Spohn-Texas A&M Emergency Medicine Residency conducted a retrospective analysis of the FDA’s Manufacturer and User Device Experience (MAUDE) database, a post-market surveillance system that collects voluntary “reports on adverse events involving medical devices.” [ii] Their report is summarized here.
Public awareness about AEDs and the need for bystander intervention is very low. Most people are unable to recognize an AED and would be unwilling to use them . [xii] The incidence of AED use by laypersons in cases of out-of-hospital cardiac arrest is also very low (2% [xiii] -4% [xiv] ).
An automated external defibrillator (AED) is a device that delivers that shock. It analyzes the heart rhythm and if necessary, provides instructions on how to deliver it.
The AED is designed to tell you exactly what you need to do. It keeps pace with what you are doing and adapts its instructions so that it doesn’t overwhelm, run ahead, or slow you down. If necessary, it will repeat the prompts, rephrasing them or adding additional instruction to help you understand.
Choose locations that increase the chances of getting the AED to the person having an SCA in less than three minutes. Elevators, cafeterias, and reception areas are all good locations for AEDs. Philips representatives can help you determine how many AEDs are recommended for your organization and where to place them.
Then Life Guidance acts as your personal coach, guiding you through a cardiac emergency with a simple, step-by-step process. A calm, clear voice walks you through the entire rescue at your own pace.
A heart attack victim has a pulse but an SCA victim does not. You don’t have to remember these distinctions. When the AED instructs you to put the pads on the victim, it will sense the heart rhythm and determine the best steps to take, giving you guidance all along the way.
Philips AEDs are self-monitoring. They perform regular self-tests to make sure that everything is working. However, there are 2 parts that need regular replacement—the pads and the battery. The device has reminder lights to help you remember. In addition, each AED comes with a sticker reminder system.
Even if he or she is gasping for breath or having seizures, if the person is unconscious, use the AED. Don’t worry about diagnosing the victim correctly. The Philips AED will analyze the heart rhythm and tell you to deliver a shock, if and only if the victim needs it.
Philips HeartStart Home defibrillator guides you through the process of treating a victim of suspected sudden cardiac arrest.¹ The OnSite AED provides real-time guidance through step-by-step voice commands and CPR guidance.¹
When you observe someone suffering from a suspected SCA, you should act quickly. We’ve equipped Home with integrated SMART Pads. Just place the SMART Pads on the person’s bare skin, and they will provide feedback to the AED so it can adapt its voice instructions to your actions and your pace. The SMART Pads sense when they have been placed on the patient and when you’ve completed each step. The system won’t announce the next step until you are ready. Prompts are repeated and rephrased, and include additional instruction to aid understanding.
Fast, shock delivery. Patented Quick Shock typically administers a shock just eight seconds after CPR, making the HeartStart Home among the fastest in its class at delivering shock treatment after CPR. Studies show that minimizing time to shock after CPR may improve survival. Show more.