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medpundit |
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Thursday, August 10, 2006During 2.78 million AED device-years of observation, 52 advisories .... affecting 385,922 AEDs and AED accessories were issued. Overall, 21.2% of AEDs distributed during the study period were recalled, most often because of electrical or software problems. The AED advisory rate did not significantly increase during the study period, although the annual number of AED advisories .... and AED advisory devices....did increase. Confirmed fatal AED-related device malfunctions occurred in 370 patients. The authors conclude that more lives are saved than harmed by the devices. After all, if you have no device, you don't even get the chance to try defibrillation. Here are some examples of the malfunctions that brought about recalls: While attempting to defibrillate a patient in cardiac arrest, the device made a loud "bang" sound and displayed an error message. The device was then unable to charge or discharge energy. While attempting to defibrillate a patient in ventricular fibrillation, an "internal dump overload" message was displayed and the device failed to discharge. Another device was obtained and the patient was defibrillated. The patient died the next day. Here's the problem - there's no way to check for those kinds of malfunctions until the device is actually being used on a patient. I have a defibrillator in my office. Every month I check it to make sure it's functioning. I turn it on to its "test mode" and it tells me whether or not the battery is charged, etc. But, I can't tell if it will work when it's supposed to. I can't do a "test shock" as it were. And, I can't test the pads and their cables that connect a machine to the person (that would be in the "accessory" category.) Their package says that once the package has been opened, the pads must be discarded. It would be nice to have a list of the recalled products. Well, someone has put one together. posted by Sydney on 8/10/2006 08:16:00 AM 0 comments 0 Comments: |
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