Defibtech Announces a Voluntary Recall of DDU-100 series AEDs

Defibtech, LLC is initiating a worldwide voluntary recall of certain DDU-100 series semi-automatic external defibrillators (AEDs) sold under the Lifeline AED and ReviveR AED brand names, including 65,885 AEDs distributed in the United States. This recall affects only DDU-100 Series AEDs shipped with 2.004 software or earlier. This corrective action addresses two possible conditions, which in rare cases may cause an affected AED to cancel shock during the charging process and not provide therapy which may result in failure to resuscitate the patient. Both conditions are not detectable by the periodic self test.

Condition 1: In rare instances, the AED may cancel charge in preparation for a shock. Based on field data, the odds of an affected AED having this happen are less than a 1 in 400,000 chance per month for any given AED.

A subset of AEDs (less than 11%) that are affected by Condition 1 are also affected by Condition 2: In rare instances, the AED may cancel charge in preparation for a shock in very high humidity conditions. The only reported cases were in environments of greater than 95% relative humidity or condensing conditions. Based on field data, the odds of an affected AED having this happen are less than a 1 in 250,000 chance per month for any given affected AED.

Defibtech will provide customers with a free software upgrade to address these issues. The correction to the AED will be able to be performed at the location where the AED is deployed.

Because both of these conditions occur very rarely, it is recommended that customers keep their AEDs in service until they have performed the software upgrade. Full instructions and recommendations are being mailed to affected customers. This customer notification, as well as instructions on determining whether an AED is affected, can also be found on the www.defibtech.com/fa111 web page. For additional information regarding this recall, please refer to the above referenced web page, contact your distributor, or contact Defibtech at techsupport@defibtech.com, 1-877-453-4507 or 1-203-453-4507.

The AEDs affected by this recall have been distributed globally to fire departments, EMS, health clubs, schools, and other organizations. The Food and Drug Administration (FDA) has determined that this action is a Class I recall. Any adverse reactions experienced with the use of this product and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800- FDA-1088, or on the MedWatch website at www.fda.gov/medwatch2.

-----

Community News You Can Use
Click to read MORE news:
www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
www.ArtsAcrossGeorgia.com
Twitter: @artsacrossga, @softnblue, @RimbomboAAG @FayetteFP

Defibtech Announces a Voluntary Recall of DBP-2800 Battery Packs used in the Lifeline AED® and ReviveR AEDTM

Defibtech, LLC, is initiating a voluntary recall of 5,418 DBP-2800 Battery Packs used in the Lifeline AED® and ReviveR AEDTM (semi-automatic external defibrillators). This recall affects all DBP- 2800 Battery Packs shipped prior to June 4, 2007. In rare instances, when the AED is used with an affected battery pack, the AED may falsely detect an error condition during charging for a shock, then cancel charge and not provide therapy. Defibtech determined the need for this recall after learning of four reports from end users of this malfunction during patient use.

The company has identified recommendations for the end customer to follow until the battery pack has been corrected, which allows the battery pack to remain in service. A copy of these recommendations is being mailed to all affected customers. This customer notification, as well as instructions on determining whether a battery pack is affected, can also be found on the www.defibtech.com/batteryFA1 web page. For additional information regarding this recall, please refer to the above referenced web page, contact your distributor, or contact Defibtech at techsupport@defibtech.com, 1-877-453-4507 or 1- 203-453-4507.

Defibtech will provide customers with a free battery pack update card to address this issue for all affected battery packs. The correction to the battery pack will be able to be performed at the location where the battery pack is deployed using any DDU-100 series AED and a Defibtech supplied battery pack update card. The battery pack update is expected to be available within the next two weeks.

The DBP-2800 battery packs affected by this recall have been distributed globally to fire departments, EMS, health clubs, schools, and other organizations. The affected battery packs are used in AEDs which can be identified by the words "Lifeline AED®" and "ReviveR AEDTM" on the front of the device.

The Food and Drug Administration (FDA) has determined that this action is a Class I recall. Any adverse reactions experienced with the use of this product and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800- FDA-1088, or on the MedWatch website at www.fda.gov/medwatch2.

------
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow us on Twitter:  @GAFrontPage