Class I Medical Device Recall: Defibtech LLC, DBP-2800 Battery Pack for ReviveR AED? and Lifeline AED® Semi-automatic Exter
Posted Jun 13 2010 9:00pm
Recall Class: Class I
Date Recall Initiated: May 21, 2010
Product(s): DBP-2800 Battery Pack for the Defibtech ReviveR AED™ and Lifeline AED® semi-automatic external defibrillators
Affects only DBP-2800 battery packs distributed prior to June 4, 2007 and used with the ReviveR AED™ and Lifeline AED® devices.
Affected battery pack serial numbers range:
Between 202001005 and 202005916, or,
Between 206001001 and 206009871
In a letter to customers dated May 20, 2010, Defibtech states that the company is mailing to all affected customers a battery pack update data card that will allow customers to update device software to correct the problem while allowing the devices to remain in their locations.
Reason for Recall: If the AED is used with an affected battery pack, the AED may falsely detect an error condition, cancel charge and not provide therapy.
Use: The intended use for the semi-automatic external defibrillator, which includes the DBP-2800 battery pack, is for use on victims of sudden cardiac arrest when the patient is unconscious, unresponsive, and not breathing.
741 Boston Post Road, Suite 201
Guilford, Connecticut 06483-3921
Defibtech Technical Support at email@example.com or call 1-877-453-4507 or 1-203-453-4507, 8:30 A.M. to 5:00 P.M. (Eastern Time), Monday - Friday.
FDA District: New England
The following are Defibtech's immediate recommendations
Determine if your battery pack is affected by this correction by following the steps on the company website.
If your battery pack is affected by this correction, keep your DDU-100 series AED and battery in service until you have received your battery pack update card from Defibtech and have updated your battery pack. Make sure that you have a replacement battery pack available, and arrange for a backup AED if you do not have a replacement battery pack available.
If during a rescue, your AED cancels shock and shuts down with a service code 1003, replace the battery pack and proceed with the rescue. If this condition occurs, the AED containing an affected DBP-2800 battery pack will announce "Shock Cancelled", "Service Code 1003", "Powering Off".
If your battery pack is not affected by this correction, keep your DDU-100 series AED and battery in service and maintain it in accordance with the User Manual.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.