Events

Retiro De Equipo (Recall) de CARDIOSAVE SYSTEM - HYBRID & RESCUE INTRA-AORTIC BALLOON PUMP

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MAQUET-DYNAMED INC..

¿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
    105383
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-04-05
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Maquet continually monitors the performance of the cardiosave iabps and has discovered four issues that could affect the cardiosave iabp performance and may cause the cardiosave iabp to not meet performance specifications. the scroll compressor may not meet the performance specifications for output pressure or vacuum at specific flow rates. due to an unintended increased size in the his/cis connectivity packet the interface may reject the packet due to increased packet size and the his/cis may not be able to provide external data communications of electronic medical records as intended. the cardiosave iabp may have intermittent connectivity issues causing display blanking followed by a "system failure" audible alarm and shut down. during operation the cardiosave iabp may shutdown due to a short on the video generator board. intermittent connection with the cardiosave pneumatic module connector may result in iabp startup failure and/or iabp shutdown.

Device

CARDIOSAVE SYSTEM - HYBRID & RESCUE INTRA-AORTIC BALLOON PUMP
  • Modelo / Serial
    Model Catalog: 0998-00-0800-53 (Lot serial: > 10 NUMBERS CONTACT MFG)
  • Descripción del producto
    CARDIOSAVE SYSTEM - HYBRID & RESCUE INTRA-AORTIC BALLOON PUMP
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    HC