Events

Safety Alert Or Field Safety Notices for Lucas external cardiac compressor

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 Jolife AB.

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 ID
    MDA/2007/013
  • Event Number
    CON2030218
  • Date
    2007-02-06
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2030218
  • 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
  • Reason
    The mhra has received reports of: inadequate ventilation in non-intubated patients thoracic cage and lung damage raised levels of atmospheric oxygen in ambulances where the device is powered by an oxygen supply.
  • Action
    Ensure that all users of this device are aware of the ventilation update to the instructions for use from Jolife AB, appended to this Alert. This now states that when used in non-intubated patients the device can be safely stopped to allow intermittent manual ventilation. Ensure the device is placed correctly, according to its instructions for use (IFU). If the device is powered by oxygen and used in confined spaces (e.g. ambulances) ensure there is adequate ventilation. In ambulances always run the ventilation at the highest capacity and do not recirculate the air. If the device is powered by oxygen always ensure there is an adequate oxygen supply for both the Lucas device and the patient’s respiratory requirements.

Device

Lucas external cardiac compressor
  • Model / Serial
  • Product Description
    Lucas external cardiac compressor, manufactured by Jolife AB and distributed by Medtronic Ltd. The Lucas external cardiac compressor is used for external cardiac chest compressions on adult patients who have acute circulatory arrest. The manufacturer defines this as the absence of spontaneous breathing, no pulse and the loss of consciousness. This device is only intended for temporary use where manual resuscitation would otherwise be used. The model of device presently used in the UK, with serial numbers up to and including 14063999, is powered by either oxygen or medical air from the wall outlets of hospitals and ambulances, or from cylinders. This model was manufactured up to May 2006 and uses IFU 100081-00 Rev B. Copies of the device’s instructions for use and its ventilation update, are available from the manufacturer’s website www.lucascpr.com/lucas.php?sid=9 (external link) Device users should ensure they use the appropriate instructions for their device, as there is a new model with serial numbers from 14064000 which is powered by medical air only.
  • Manufacturer
    Jolife AB

Manufacturer

Jolife AB
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    MHRA