Events

Alerte De Sécurité sur LUCAS 2 Chest Compression System

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Jolife AB.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2018-02-23
  • Date de publication de l'événement
    2018-02-23
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180223b.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: jolife ab lucas 2 chest compression system the therapeutic goods administration (tga) of australia has issued a medical device safety alert concerning lucas 2 chest compression system [item number: 3302430-145; multiple affected serial numbers; manufactured between september 2014 and april 2015], manufactured by jolife ab. the manufacturer has become aware of a potential reliability issue where the lucas device may not respond to the push of certain buttons due to potential damage of an internal cable. the user control panel cable can be damaged by rubbing against an adjacent cable connector. if the malfunction were to occur, it may cause the device to exhibit one of the following: the device does not change from one active mode to the other the device does not begin compressions the device does not temporarily stop and lock in the start position when the pause button is pressed the manufacturer will arrange for replacement of an internal cable. users are advised to refer to sections 3.8 and 5.4 of the instruction for use, which states that if there are interruptions, if the compressions are not sufficient, or something unusual occurs during operation: push on/off for 1 second to stop lucas and remove the device from the patient. immediately start manual chest compressions. for details, please refer to the tga’s website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2018-rn-00147-1 posted on 23 february 2018.

Device

LUCAS 2 Chest Compression System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Jolife AB LUCAS 2 Chest Compression System
  • Manufacturer
    Jolife AB

Manufacturer

Jolife AB
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DH