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Showing posts with label defibrillator. Show all posts
Showing posts with label defibrillator. Show all posts

Tuesday, May 3, 2011

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.

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Wednesday, June 9, 2010

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.

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Wednesday, February 10, 2010

Cardiac Science Notifies AED Customers of Voluntary Medical Device Recall

Cardiac Science Corporation [NASDAQ: CSCX] is initiating a worldwide voluntary recall after determining that approximately 12,200 automated external defibrillators (AEDs) may not be able to deliver therapy during a resuscitation attempt, which may lead to serious adverse events or death. These AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions. The FDA has been informed of this situation.

This issue is separate from the Company’s November 13 announcement regarding a voluntary medical device correction. Each of the approximately 12,200 devices affected in this recall can be confirmed at the Cardiac Science Web site at http://www.cardiacscience.com/AED1951.

Cardiac Science detected this issue through its internal quality systems and has received no complaints or reports of this problem in the field. The affected AEDs were manufactured or serviced between October 19, 2009 and January 15, 2010 and include the following models:

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o Powerheart 9300A, 9300E, 9300P, 9390A, 9390E
o CardioVive 92532
o CardioLife 9200G and 9231

Customers who received any of these AED models since October 19, 2009 can visit http://www.cardiacscience.com/AED1952 to determine if they have an affected AED. Each affected AED should immediately be removed from service since it may not deliver the expected therapy.

All affected AEDs will be replaced at no charge to the customer. Cardiac Science will contact customers by letter and will provide them with replacement AEDs as soon as they are available. Replacement shipments are anticipated to begin February 15.

The Company expects to record a charge of between $2.0 and $3.0 million in the fourth quarter of 2009, reflecting its current estimate of the expected costs relating to this action. Actual costs may vary based on a variety of factors. Cash expenditures relating to replacement of the affected AEDs will occur in the first half of 2010. The company does not currently believe this action will have a significant adverse impact on its ability to fulfill AED orders for the first quarter.

Customers may contact the Company immediately at 888.402.2484 within the United States. Outside the US, customers can contact +44.161.926.0011 or the local Cardiac Science representative. Customers can also email the company at aed195@cardiacscience.com for more information.

Forward-Looking Statements

This press release contains forward-looking statements. The word "believe," "expect," "intend," "anticipate," variations of such words, and similar expressions identify forward-looking statements, but their absence does not mean that the statement is not forward-looking. Forward looking statements in this press release include, but are not limited to, those that refer to the timing and volume of shipment of replacement AEDs, order volume and fulfillment, the timing and amount of expenses to be recorded in the Company’s financial statements relating to the replacement of affected AEDs, and the timing and amount of associated cash expenditures. These are forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results and performance may vary significantly from those expressed or implied in such statements. Factors that could cause or contribute to such varying results and other risks are more fully described in the Annual Report on Form 10-K filed by Cardiac Science Corporation for the year ended December 31, 2008, as updated by subsequent quarterly reports on Form 10-Q. Cardiac Science Corporation undertakes no duty or obligation to update the information provided herein.

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