Events

Recall of HIGH-USE BATTERY PACK

According to Health Canada (via FOI), this recall involved a device in Canada 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
    18220
  • Event Risk Class
    I
  • Event Initiated Date
    2010-04-29
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The product under recall is the dbp2800 battery pack which is used to power the ddu100 semiautomatic external defibrillator (aed). in rare instances when the aed is used with an affected battery pack the aed may falsely detect an error condition cancel charge and not provide therapy. this situation can occur only with dbp-2800 battery packs shipped prior to june 4 2007. although the probability of this condition is very low as a precaution defibtech is correcting all potentially affected batteries. no occurrences have been reported in canada.

Device

HIGH-USE BATTERY PACK
  • Model / Serial
    Model Catalog: DBP-2800 (Lot serial: Model DBP-2800); Model Catalog: DBP-2800 (Lot serial: units shipped before Jun 407)
  • Product Classification
    Cardiovascular Devices
  • Product Description
    DBP-2800 Battery Pack
  • Manufacturer
    DEFIBTECH LLC

Manufacturer

DEFIBTECH LLC