Events

Retiro De Equipo (Recall) de Harris Oxygen Flowmeter

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por HGEA 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-2015-RN-00266-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-04-15
  • 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-2015-RN-00266-1
  • 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
    Fisher & paykel healthcare pty ltd is issuing this recall for product correction on behalf of the harris products group as there have been two reports of confusion due to mislabelled measurement lines on the model 86630lox flowmeter. the measurement lines are labelled for arco2 gas and not oxygen gas. there have been no reports of injury to date, however there is potential to set up an incorrect flow of oxygen or air gas to a patient.Note: even though there have been no reports involving the air flow meter, it is being included in this recall as it also uses an arco2 labelled tube.
  • Acción
    Harris Products Group is supplying the correction labels to all affected customers. This label is to be affixed to the flow meter to correctly read the flow of Oxygen or Air gas.

Device

Harris Oxygen Flowmeter
  • Modelo / Serial
    Harris Oxygen FlowmeterModel Numbers: 86630LOX and 86630LAIR (labelled as “Model 866”)All Lot Numbers ARTG No. 140296
  • Manufacturer
    HGEA Pty Ltd

Manufacturer

HGEA Pty Ltd