Events

Notificaciones De Seguridad De Campo acerca de Laerdal Suction Unit

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Laerdal Medical.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2016-09-27
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    In order to ensure that your laerdal suction unit (lsu) is in compliance with iso 10079-11, one of the following actions described as option 1 and option 2 below must be taken. please read the below information carefully and report back to laerdal on the attached customer response form within three weeks. option 1: where the lsu is not stored or installed in cold temperatures - re-label the lsu with revised conditions at which the lsu can be stored and installed before operation if this is the case, you may continue to use the lsu without any changes to the unit. in order to inform end-users of the lsu about the limitation in operating conditions, we ask you to re-label your lsu with the revised operating conditions 12 °c to 40 °c (54 °f to 104 °f). to re-label your lsu, a new operating conditions label provided by laerdal medical is required. when labelled according to these instructions, the lsu complies with iso 10079-1 without need of any further actions. if you decide to re-label your lsu with revised operating conditions – please complete section 1 of the customer response form. in the response form, we ask you to specify the number of lsu units that are currently in use, so that laerdal medical may provide you with a suitable number of labels. .

Device

Laerdal Suction Unit

Manufacturer

Laerdal Medical