Guest guest Posted November 19, 2004 Report Share Posted November 19, 2004 MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and Access CardioSystems, Inc. notified the public of the Class 1 recall of Access CardioSystems Automated External Defibrillators (AEDs), used for the treatment of cardiac arrest by hospitals, fire departments and emergency medical services personnel. Approximately 10,000 devices are in distribution. One or both of the following problems may occur - 1] the defibrillator may fail to deliver a shock due to a faulty circuit board, and 2] the defibrillator may turn on unexpectedly causing the " on/off " switch to become inoperative, making the device unable to defibrillate. Customers should immediately stop using the recalled devices. Read the MedWatch 2004 safety summary, including a link to the FDA recall notice and press release, at: http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#Access -------- Thank you for using MedWatch as a trusted source for timely safety information on drugs and other medical products regulated by the U.S. Food and Drug Administration. If you find this e-mail notification helpful, please consider telling colleagues and friends about MedWatch. They can learn more about us and subscribe/unsubscribe to the e-list at the MedWatch homepage, http://www.fda.gov/medwatch or by going directly to http://list.nih.gov/cgi-bin/wa?SUBED1=medwatch & A=1 This is an automated message delivery system -- replying to this message will not reach MedWatch staff. If you have comments or questions about MedWatch or this e-mail, please contact us through our comments & feedback web page, http://www.fda.gov/medwatch/feedback.htm Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 19, 2004 Report Share Posted November 19, 2004 That's really nice of them. Actually, I put this information out there in case anybody was using them and didn't know about the problems inherent in this model. . . Rick LaChance, EMT-LP Media Lab Director Emergency Medicine Education UT Southwestern Medical Center Dallas, TX 75390-9134 Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 19, 2004 Report Share Posted November 19, 2004 That's really nice of them. Actually, I put this information out there in case anybody was using them and didn't know about the problems inherent in this model. . . Rick LaChance, EMT-LP Media Lab Director Emergency Medicine Education UT Southwestern Medical Center Dallas, TX 75390-9134 Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 19, 2004 Report Share Posted November 19, 2004 That's really nice of them. Actually, I put this information out there in case anybody was using them and didn't know about the problems inherent in this model. . . Rick LaChance, EMT-LP Media Lab Director Emergency Medicine Education UT Southwestern Medical Center Dallas, TX 75390-9134 Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 19, 2004 Report Share Posted November 19, 2004 FYI: http://accesscardiosystems.com/ More FYI: http://www.concordmonitor.com/apps/pbcs.dll/article?AID=/20041116/REPOSITORY /411160322/1003/BUSINESS Even More FYI: http://www.wisconsinems.com/ E. Bledsoe, DO, FACEP Midlothian, TX http://www.bryanbledsoe.com FDA AED Recall MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and Access CardioSystems, Inc. notified the public of the Class 1 recall of Access CardioSystems Automated External Defibrillators (AEDs), used for the treatment of cardiac arrest by hospitals, fire departments and emergency medical services personnel. Approximately 10,000 devices are in distribution. One or both of the following problems may occur - 1] the defibrillator may fail to deliver a shock due to a faulty circuit board, and 2] the defibrillator may turn on unexpectedly causing the " on/off " switch to become inoperative, making the device unable to defibrillate. Customers should immediately stop using the recalled devices. Read the MedWatch 2004 safety summary, including a link to the FDA recall notice and press release, at: http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#Access -------- Thank you for using MedWatch as a trusted source for timely safety information on drugs and other medical products regulated by the U.S. Food and Drug Administration. If you find this e-mail notification helpful, please consider telling colleagues and friends about MedWatch. They can learn more about us and subscribe/unsubscribe to the e-list at the MedWatch homepage, http://www.fda.gov/medwatch or by going directly to http://list.nih.gov/cgi-bin/wa?SUBED1=medwatch & A=1 This is an automated message delivery system -- replying to this message will not reach MedWatch staff. If you have comments or questions about MedWatch or this e-mail, please contact us through our comments & feedback web page, http://www.fda.gov/medwatch/feedback.htm Quote Link to comment Share on other sites More sharing options...
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