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-2017-RN-00490-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-04-19
  • 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-00490-1
  • 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 an investigation of the reported customer complaints, the manufacturer has identified that there is a potential for some circuits of the affected batches to operate incorrectly. the 10mm female connector was slightly oversized during its manufacturing and therefore the device could become loose from the fisher & paykel neopuff’s 10mm male connector under certain conditions and would therefore not deliver the required pressure to the patient.
  • Acción
    Affected Lots are being recalled from Hospitals. Users are requested to note this is an expanded recall from December 2016 where this issue was first identified and Batch Number: TB2000-0141 was recalled.

Device

TB2000 Disposable t-piece infant resuscitation circuit with adjustable PEEP
  • Modelo / Serial
    TB2000 Disposable t-piece infant resuscitation circuit with adjustable PEEPThis Recall:- Batch / Lot Number: TB2000-0146, TB2000-0149 and TB2000-0151Previous Recall from December 2016:- Batch / Lot Number: TB2000-0141ARTG Number: 188097
  • Manufacturer
    Swirl Technologies Pty Ltd T/A Parker Healthcare

Manufacturer

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