Events

Retiro De Equipo (Recall) de Balloon pump

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Datascope Corporation.

¿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
    21730
  • Fecha de inicio del evento
    2017-07-27
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Maquet Australia Pty Ltd (NZ), 12G Andromeda Cres East Tamaki, Auckland 2013
  • Causa
    The manufacturer has received complaints involving the cs100/cs100i and cs300 iabps regarding the following issues:, " false blood detection alarm, and, " the ingress of fluids into the iabp affecting various electronic circuit boards., either issue could potentially prevent initiation or continuation of therapy.
  • Acción
    Manufacturer to issue advice regarding use

Device

Balloon pump
  • Modelo / Serial
    Model: , Affected: CS100 and CS300 Intraortic Balloon Pumps, also applies to any System 98 or System 98XT IABP which was converted to a CS100i or CS300 IABP.
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Datascope Corporation

Manufacturer

Datascope Corporation
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    NZMMDSA