Z-1781-2010
Lifeline AED DDU-100 semiautomatic external defibrillator used with the DBP-2800 Battery Pack, Manufactured...
Defibtech LLC / initiated 2010-05-21 / Terminated / root cause: design
Defibtech LLC began a recall of Lifeline AED DDU-100 semiautomatic external defibrillator used with the DBP-2800 Battery Pack, Manufactured by Defibtech, LLC. Seymour, CT 06483. The DBP-2800... 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-1781-2010
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Defibtech LLC
- Product
- Lifeline AED DDU-100 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.
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