Events

Alerte De Sécurité sur Liko Bathing Chair

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Liko 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
    2012-10-10
  • Date de publication de l'événement
    2012-10-10
  • 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_20121010a.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: liko bathing chair it has come to our attention that medical device manufacturer, liko ab (a hill-rom company) has issued a field safety notice regarding all serial numbers of bathing chair with the following model numbers: 3156025 and p3156025. the liko bathing chair is an accessory to overhead lift devices. an event occurred in a public pool area in sweden where it was alleged that a patient fell out of the chair during a lift. the patient allegedly suffered serious injuries. the complaint investigation revealed the device was used without securing the safety belt, which is designed to keep the patient stabilized in the chair during the lift. the safety belt is secured to the chair and cannot be moved. it cannot be unnoticed to be used as part of the safe use of the device. the manufacturer has assessed the risk not likely to occur again in the lifetime of the device. the manufacturer has created a label reminding users to secure the patient with the safety belt and a new user instruction guide on how to safely use the chair. a modification kit including the label and an updated user guide will be sent to affected users. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 10 october 2012.

Device

Liko Bathing Chair
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Liko Bathing Chair
  • Manufacturer
    Liko AB

Manufacturer

Liko AB