Events

Recall of Defibtech Lifeline AED and ReviveR AED

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
    58160
  • Event Risk Class
    Class 1
  • Event Number
    Z-2064-2011
  • Event Initiated Date
    2011-04-01
  • Event Date Posted
    2011-05-16
  • 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=98564
  • 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
    Software with version 2.004 software or earlier may cause an affected aed to cancel shock during the charging process.
  • Action
    The firm, Defibtech, sent an "URGENT MEDICAL DEVICE SAFETY INFORMATION AND CORRECTION" letter dated March 11, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) Remove the pads from the storage pouch on the back of their DDU-100 series AED and inspect the 9-digit serial number label. 2)Carefully note the 9-digit serial number on the back of the AED, then visit the Defibtech website at www.defibtech.com/fa11 and enter their serial number to determine if their AED is affected; email their serial number and contact information to fa@defibtech.com or call Defibtech directly at 1-877-453-4507 or 1-203-453-4501 and Defibtech will inform them if their unit is affected. 3) If their AED is affected, confirm receipt of this notification with Defibtech as soon as possible by website and/or confirmation card. Complete and return the confirmation form via fax to 1-203-738-1072. Note: "it is very important for you to contact us either through the Defibtech website or return this card to confirm that you have received this notice. This information will expedite the process of upgrading your AEDs." If your DDU-100 series AED serial number DOES NOT fall within the listed range, your AED is not affected by this recall. A letter was also sent to the distributors and direct accounts that have received the affected product by first class mail with a prepaid, return written acknowledgement card. The field action consists of a software change to the AED. All affected AEDs operating with software version 2.004 or earlier are to remain in the field and in service throughout the field action process. Upon receipt of contact information from affected customers, Defibtech will send an upgrade kit to customers consisting of a software data card, instructions on how to perform the upgrade, and a pre-paid upgrade confirmation postcard that must be returned to Defibtech upon completion

Device

Defibtech Lifeline AED and ReviveR AED
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: AUSTRALIA, AUSTRIA , BAHRAIN, BRAZIL, CANADA, CHILE, CHINA , CYPRUS, CZECH REPUBLIC, EGYPT, EL SALVADOR, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JORDAN, KOREA, REPUBLIC OF LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NORWAY, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM AND URUGUAY.
  • Product Description
    Defibtech Lifeline AED and ReviveR AED, || Model: DDU-100 Series AEDs || Software version 2.004 or earlier || The product under correction is the DDU-100 AED. The AED is indicated for use on victims of sudden cardiac arrest (SCA) when the patient is unconscious, unresponsive and not breathing. The indications for use also state that for patients under 8 years old, child/ infant electrode pads are to be used and that therapy should not be delayed to determine the patients exact age or weight. The AED must also be used by or on the order of a physician. These AEDs are sold under the brand names Lifeline AED and ReviveR AED.
  • Manufacturer
    Defibtech, LLC

Manufacturer

Defibtech, LLC
  • Manufacturer Address
    Defibtech, LLC, 741 Boston Post Rd Ste 201, Guilford CT 06437-2714
  • Source
    USFDA