Events

Retiro De Equipo (Recall) de TB2000 Disposable t-piece infant resuscitation circuit with adjustable PEEP

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Swirl Technologies Pty Ltd T/A Parker Healthcare.

¿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-01577-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-12-06
  • 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-01577-1
  • 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
    During investigation of the reported complaints from the field, the manufacturer has identified that there is a potential for some circuits of the affected batch to operate incorrectly. the 10 mmf connector of the circuits was slightly oversized during its manufacturing and therefore the device could become loose from the fisher & paykel neopuff’s 10 mmm connector under certain pressure and would not deliver the required pressure to the patient.
  • Acción
    All remaining TB2000 circuits from the affected Batch TB2000-0141 will be replaced with unaffected batches without any additional costs to the customer. Customers are advised to isolate the affected units and contact Parker Healthcare Customer Service Department or their sales representative to organise the return of the recalled stock and to get replacement stock. This action has been closed-out on 26/05/2017.

Device

TB2000 Disposable t-piece infant resuscitation circuit with adjustable PEEP

Manufacturer

Swirl Technologies Pty Ltd T/A Parker Healthcare
  • Source
    DHTGA