Events

Alerte Ou Avis De Sécurité sur Lucas external cardiac compressor

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Jolife AB.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2007/013
  • Numéro de l'événement
    CON2030218
  • Date
    2007-02-06
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2030218
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    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
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    MHRA