Events

Retiro De Equipo (Recall) de Laerdal Compact Suction Unit 4 (LCSU 4) (portable suction unit intended for field and transport use)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Laerdal Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-01529-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-24
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01529-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Laerdal medical has become aware of a problem related to the on/off functionality of the lcsu 4. the on/off functionality is controlled by electronic components and one of these components might be damaged. the damage occurs over time when the unit is connected to a power source (battery or external power source), but is not related to frequency of use. a damaged component will result in failure of the on/off functionality whereby the lcsu 4 cannot be turned off, and it may turn on by itself. the unit can be turned off by removing the battery or the external power source.
  • Acción
    Laedral will be providing replacement units. In the interim, Laedral is advising users to perform a test to identify if their unit has failing On/Off functionality, by turning the unit on then turning it off again. If the unit cannot be turned off using the On/Off button, the unit contains a damaged component and the device should be taken out of service. If the unit passes the test, the device can continue to be used until the replacement unit is received, but the following extra safety measures should be implemented: - Store the LCSU 4 unit without the battery connected. - Perform routine checks of the On/Off functionality by turning the unit on and off using the On/Off button. If the On/Off functionality fails during clinical use, the unit can continue to be used so long as it has power. The unit can be turned off by removing the battery or the external power source.

Device

Laerdal Compact Suction Unit 4 (LCSU 4) (portable suction unit intended for field and transport use)
  • Modelo / Serial
    Laerdal Compact Suction Unit 4 (LCSU 4) (portable suction unit intended for field and transport use)LCSU 4, 300ml Complete unitItem Number: 88006140LCSU 4, 800ml Complete unitItem Number: 88005140 Units manufactured from 1 May 2015 to 28 October 2016 that do not have 'RW' on labelARTG Number: 205931
  • Manufacturer
    Laerdal Pty Ltd

Manufacturer

Laerdal Pty Ltd