Events

Recall of PEDIATRIC ECG/DEFIB/PACING RADIOTRANSLUCENT PADS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CONMED CANADA.

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
    72752
  • Event Risk Class
    I
  • Event Initiated Date
    2014-11-17
  • 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
    Philips healthcare has made changes to the design of the connection between multifunction electrodes and their heartstart fr3 and heartstart frx aeds. because of this change conmed's multifunction electrodes listed above will not connect to these aeds. the heartstart frx aed unit requires the pads to be pre-connected and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. the heartstart fr3 however does not require pre-connection and the user will not discover the compatibility issue until the aed must be used. in this circumstance the failure to connect may result in a delay of therapy which could result in patient death or serious injury. conmed's padpro and r2 devices still work with other phillips aeds which accept plug style connectors. philips healthcare heartstart fr3 and heartstart frx aed units should only be used with the philips brand electrodes specified in the philips medical equipment manuals. conmed's labeling has been updated accordingly.

Device

PEDIATRIC ECG/DEFIB/PACING RADIOTRANSLUCENT PADS
  • Model / Serial
    Model Catalog: 2602H (Lot serial: ALL LOT CODES); Model Catalog: 2603H (Lot serial: ALL LOT CODES); Model Catalog: 2516H-PC (Lot serial: ALL LOT CODES); Model Catalog: 2516H (Lot serial: ALL LOT CODES); Model Catalog: 2001H (Lot serial: ALL LOT CODES); Model Catalog: 2001H-C (Lot serial: ALL LOT CODES); Model Catalog: 2001H-PC (Lot serial: ALL LOT CODES)
  • Product Classification
    Cardiovascular Devices
  • Product Description
    PEDIATRIC RADIOTRANSLUCENT ELECTRODE AND MINI PEDIATRIC RADIOTRANSLUCENT ELECTRODE
  • Manufacturer
    CONMED CANADA

Manufacturer

CONMED CANADA
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    HC