Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1782-2010

ReviveR AED semiautomatic external defibrillator used with the DBP-2800 Battery Pack. Manufactured by...

Defibtech LLC / initiated 2010-05-21 / Terminated / root cause: design

Defibtech LLC began a recall of ReviveR AED semiautomatic external defibrillator used with the DBP-2800 Battery Pack. Manufactured by Defibtech, LLC. Seymour, CT 06483. The DBP-2800 battery... on . The reason FDA records is "The AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and not provide therapy". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1782-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Defibtech LLC
Product
ReviveR AED semiautomatic external defibrillator used with the DBP-2800 Battery Pack. Manufactured by Defibtech, LLC. Seymour, CT 06483. The DBP-2800 battery pack is an accessory to the AED and does not have its own intended use. The AED is intended for use on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing.
Product code
MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall
The AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and not provide therapy
Root cause tag
design
FDA root cause
Device Design
Action
Defibtech, LLC issued an "Urgent Medical Device Safety Information and Correction" notification dated May 20, 2010 by email and hard copy via US Mail. The notification instructed Consignees on proper identification of affected product and steps to take for product replacement. For further information, contact your distributor or Defibtech Technical Support at [email protected] or call 1-877-453-4507 or 1-203-453-4507, 8:30 AM to 5:00 PM Monday - Friday, EST.
Distribution
Worldwide Distribution -- United States, Canada, Australia, Jordan, Spain, Israel, UK, Poland, Italy, Netherlands, Malaysia and Ireland.
Product codes and lots
Serial Numbers range from 202001005 through 202005916 and 206001001 through 206009871.