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.
FDA Recall Z-1782-2010 · Posted 2010-06-10
Advertisement
Recalling FirmDefibtech LLC
Recall StatusTerminated
Product CodeMKJ
Date Initiated2010-05-21
Date Terminated2020-09-29
Reason for Recall
The AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and not provide therapy
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution -- United States, Canada, Australia, Jordan, Spain, Israel, UK, Poland, Italy, Netherlands, Malaysia and Ireland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement