Events

Retiro De Equipo (Recall) de Mutiple Laerdal Suction Units (LSU) with NiMH Battery

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-00973-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-29
  • 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-00973-1
  • 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 use of the laerdal suction unit (lsu) when used with the lsu nimh battery that has been stored or installed at low temperatures for a prolonged period. the problem may occur if the lsu with a nimh battery, or the nimh battery itself, when the core temperature of the battery is low, typically between 0°c and 9°c. if used with a nimh battery with low core temperature, the lsu may shut off after some seconds when operated at 350 mmhg or 500+ mmhg (46.6 kpa or 66.5+ kpa) settings. if nimh battery has been stored at temperatures above 9 °c, and used at low temperatures, use should not be affected.
  • Acción
    Laerdal is providing users with the optimised vacuum settings depending on the battery core temperature. Users are advised to install or store the batteries in locations where temperatures are above 9°C.

Device

Mutiple Laerdal Suction Units (LSU) with NiMH Battery
  • Modelo / Serial
    Mutiple Laerdal Suction Units (LSU) with NiMH BatteryLSU with Resuable Canister Product Code: 78000003 LSU with Abbot Receptal canister Product Code: 78001003 LSU with Bemis Canister Product Code: 78002001 LSU with Serres Suction Bag Canister System Product Code: 78003003 All serial numbers affectedARTG Number: 129688
  • Manufacturer
    Laerdal Pty Ltd

Manufacturer

Laerdal Pty Ltd