Events

Recall of Device Recall ReviveR AED semiautomatic external defibrillator used with the DBP2800 Battery Pack

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Defibtech LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55497
  • Event Risk Class
    Class 1
  • Event Number
    Z-1782-2010
  • Event Initiated Date
    2010-05-21
  • Event Date Posted
    2010-06-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90995
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Reason
    The aed when used with an affected battery pack, may falsely detect an error condition, cancel charge and not provide therapy.
  • 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 techsupport@defibtech.com or call 1-877-453-4507 or 1-203-453-4507, 8:30 AM to 5:00 PM Monday - Friday, EST.

Device

Device Recall ReviveR AED semiautomatic external defibrillator used with the DBP2800 Battery Pack
  • Model / Serial
    Serial Numbers range from 202001005 through 202005916 and 206001001 through 206009871.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Canada, Australia, Jordan, Spain, Israel, UK, Poland, Italy, Netherlands, Malaysia and Ireland.
  • Product Description
    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.
  • Manufacturer
    Defibtech LLC

Manufacturer

Defibtech LLC
  • Manufacturer Address
    Defibtech LLC, 4 Progress Ave, Seymour CT 06483-3921
  • Manufacturer Parent Company (2017)
    Nihon Kohden Corp.
  • Source
    USFDA