Events

Retiro De Equipo (Recall) de Ohmeda Infant Warmers (with Blenders)

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Ohmeda Medical Inc.

¿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
    15803
  • Fecha de inicio del evento
    2013-12-05
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Causa
    Oxygen and air wall or tank inlet fittings on the back panel, were reversed during assembly. as a result, this may potentially have reversed air/oxygen gas concentrations; for example, a setting of 100% oxygen could have an output of 21% oxygen, and vice versa. the settings of the blender knob will no longer be accurate in the affected units. this only impacts ge resuscitation systems with blender.
  • Acción
    Product to be modified

Device

Ohmeda Infant Warmers (with Blenders)

Manufacturer

Ohmeda Medical Inc