Events

Safety Alert Or Field Safety Notices for PadPro and R2 multifunction electrodes

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Conmed.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2015/010
  • Date
    2015-03-12
  • Event Date Posted
    2015-03-12
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/padpro-and-r2-multifunction-electrodes-risk-of-delay-to-shock
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
    Philips Healthcare has made changes to the design of the connection between electrodes and the defibrillator so some Conmed electrodes are no longer compatible.This MDA is for information only and no product needs to be returned to Conmed.The labelling on new electrodes has been updated to show compatibility.
  • Reason
    (conmed) risk of delay to shock as specific electrodes manufactured by conmed are now incompatible with some models of philips defibrillators (mda/2015/010).
  • Action
    ensure staff are aware of the information contained in the field safety notice (FSN) identify any affected product as listed in the FSN ensure that the affected electrodes are not placed with Philips Heartstart FR3 defibrillators and FRx AEDs

Device

PadPro and R2 multifunction electrodes
  • Model / Serial
  • Manufacturer
    Conmed

Manufacturer

Conmed
  • Manufacturer Address
    Gregory Connell ConMed Corporation Tel: +1 727-399-5276Email: multifunctionelectrodes@conmed.com
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    MHRA