Events

Retiro De Equipo (Recall) de Promed High Concentration Oxygen Masks, Elongated (under chin), Adult Med Concentration

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Thermo Fisher Scientific Australia 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-2017-RN-00755-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-26
  • 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-2017-RN-00755-1
  • 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
    Convatec has received multiple reports of tubing detaching from the oxygen masks either prior to use (in the packaging) or during use. the detachment of the tubing would result in loss of oxygen to the patient. an investigation determined the failure was caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector.
  • Acción
    Thermo Fisher is advising users to inspect their stocks and quarantine all units from the affected batch numbers. Thermo Fisher will arrange for stock to be recovered and replacement stock, or a credit note, to be issued.

Device

Promed High Concentration Oxygen Masks, Elongated (under chin), Adult Med Concentration
  • Modelo / Serial
    Promed High Concentration Oxygen Masks, Elongated (under chin), Adult Med ConcentrationCatalogue Numbers: PMD06001, PMD06002, PMD06003, PMD06009 and PMD06106Lot Numbers: 100914, 100551, 100550, 100574 and 100581ARTG Number: 216605
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd