Events

Recall of CARDIOHELP-I

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MAQUET-DYNAMED INC..

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
    82612
  • Event Risk Class
    III
  • Event Initiated Date
    2013-09-04
  • 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
    In certain rare instances the cardiohelp-i device may display an error message with audible alarm indicating "battery defective". the alarm will occur while booting or when the main power supply is unplugged from the main power source. this is due to a defective capacitor within the battery manager board. further when alarming the hmi (human machine interface) will gradually become black due to the hmi back light shutting down. the defective capacitor behavior leads to the shutdown of the battery booster that boosts the voltage of the batteries from 12v to 24v. this in turn leads to the state that the voltage is insufficient to ignite the backlight of the display. blood flow is not affected during the shutdown time of the hmi therefore there is no risk of circulatory impairment.

Device

CARDIOHELP-I
  • Model / Serial
    Model Catalog: 70104.8012 (Lot serial: 90410704); Model Catalog: 70104.8012 (Lot serial: 90410486); Model Catalog: 70104.8012 (Lot serial: 90410493)
  • Product Description
    CARDIOHELP-i
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC