Events

Field Safety Notices about Defibrillation electrodes for Lifepak

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Cardinal Health.

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
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    The drawing on the defibrillation electrodes manufactured by cardinal health does not meet the specifications of physio-control and shows incorrect placement of the electrodes on the baby. there are no problems with the function or function of the defibrillation electrodes, but only an incorrect drawing on the defibrillation electrodes in the package. the drawing on the electrode package shows the correct placement of the electrodes on the baby. if the user improperly installs defibrillation electrodes, it can lead to inefficient energy delivery to the patient. this can lead to failed defibrillation and serious injury or death.

Device

Defibrillation electrodes for Lifepak

Manufacturer

Cardinal Health