Events

Retiro De Equipo (Recall) de Resus-EZY Manual Resuscitator (single-use pulmonary resuscitator)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Schell Medical Corporation 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-00645-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-05-12
  • 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-00645-1
  • 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
    There have been some reported cases where the flow diverter used in these products is being cracked. the flow diverter is the blue adaptor that attaches to the patient valve. the flow diverter directs the patient’s exhaled breath to atmosphere or into a peep (positive end expiratory pressure)valve where a peep valve is being used. a cracked flow diverter can affect the peep valves ability to hold peep. as the flow diverter is on the expiratory side of the breathing system there is no effect on the resuscitators ability to deliver gas to the patient. additionally, in the event of a cracked flow diverter, there are two discrete one way valves isolating the expiratory side from the inspiratory side. thus there is no pathway by which any foreign material could enter the inspiratory side of the resuscitator. a cracked flow diverter has no affect upon the resuscitators ability to deliver gas to the patient.
  • Acción
    Schell Medical is advising users to inspect stocks for the affected lot numbers. If any of the impacted products show signs of cracking, quarantine for return and replacement by Schell as per normal procedures. This action has been closed-out on 03/02/2017.

Device

Resus-EZY Manual Resuscitator (single-use pulmonary resuscitator)
  • Modelo / Serial
    Resus-EZY Manual Resuscitator (single-use pulmonary resuscitator)Catalogue Numbers: HP-9511E, HP-9511F, HP-9511FL3, HP-9511FN, HP-9511PE, HP-9511PF, HP-9511Z, HP-9611OUENBatch Number: 061115ARTG Number: 93870
  • Manufacturer
    Schell Medical Corporation Pty Ltd

Manufacturer

Schell Medical Corporation Pty Ltd