Most AEDs Are Still Safe, Officials Say
By Tom Embrey
Despite a national recall issued by the Food and Drug Administration, manufacturers of automated external defibrillators (AEDs) which are common in Moore County, say the device is safe.
Representatives from Cardiac Science called the situation a "medical device correction," and not a recall. Officials said there is a slight chance certain models of the devices require a mandatory software update to lessen potential problems with the device. That software update is now available.
The FDA issued the recall in November. After the recall, the company issued a "voluntary field correction after it was determined certain automated external defibrillators (AEDs) may experience a rare product issue in which the AED may not be able to deliver therapy during a resuscitation attempt. Device failure may affect resuscitation of the patient, which could lead to serious adverse events or death. These AEDs have electronic components which may fail and the failure may not be detected by the device's periodic self-tests."
The affected models include the Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, and CardioVive 92531, 92532, and 92533 devices.
Those devices should be repaired or replaced, according to the FDA. The FDA also said devices needing the update should still be used to treat sudden cardiac arrest (SCA), unless another AED is available.
SCA is responsible for more than 300,000 deaths each year. SCA causes the heart to stop functioning. Studies have shown 90 percent of victims can be saved when CPR and a defibrillator are used within the first minute.
Megan Blanchard, an AED information specialist with Cardiac Science, said the affected machines should still function without the update, but the company is working to install the new software.
"We'd rather be thorough than have the chance be there (of a problem)," Blanchard said. "So we are taking action to fix 300,000 machines."
Those who purchased an AED that needs the software update received a letter from the company that details protocol for updating the software. Those with questions are asked to call the company toll-free at (877) 901-1788.
Blanchard said Cardiac Science is planning to send a technician down to Moore County next week to double check all the machines.
Moore County has more than 250 AEDs in local businesses, schools and municipal buildings, thanks to the HeartSafe Moore County program.
Southern Pines is one of the few - if not the only - towns in North Carolina to be designated as a "HeartSafe Community" by the American Red Cross. That means an AED is two or three minutes from any location in the downtown where a person might suffer sudden cardiac arrest.
The Moore County chapter of the American Red Cross has received "a couple of calls" this week from people expressing concerns about their AEDs, said Buddy Spong, executive director of the Moore County Chapter of the American Red Cross and vice chairman of HeartSafe Moore County.
"The likelihood they (AEDs) will have a problem is slim," Spong said. "What we are telling people is, as long as it looks normal and the green light is on, then the machine should be fine," he said.
Blanchard said the green light Spong referred to is the device's alert monitor. When it is green, the device is ready to be used. If there is a problem with the device, the indicator turns red.
Spong said he regularly checks many of the AEDs in town, and he has had only one problem with an AED. He said it was related to the cold weather, not to a software problem. The problematic device was repaired.
Blanchard urged those who have the devices to check them regularly as well as keep up with the required maintenance. One key piece of equipment is the 2- to 3-foot cord that is used for upgrades, among other things, and is key to transmitting information from the device to doctors when a patient is transported to the hospital Blanchard said the company is finding more and more that the cord is getting separated from the device.
Contact Tom Embrey by e-mail at email@example.com.
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