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
    103412
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-02-04
  • 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
    Since the commencement of commercialization of the cardiosave hybrid intra-aortic balloon pumps (iabp) in december 2011 maquet has received thirteen (13) power supply complaints that were determined to be related to suboptimal thermal management. it is important to note that none of the thirteen complaints identified any adverse patient events. suboptimal thermal management of the power supply may result in the power supply not providing the correct output voltage to the cardiosave hybrid iabp console and the inability to charge the batteries. failure to provide the correct output voltage to the console will result in the unit not functioning from ac power even when plugged into an active electrical outlet. should a power supply malfunction occur an on screen message will alert the healthcare provider that the cardiosave hybrid iabp unit is operating on battery power.

Device

CARDIOSAVE SYSTEM - HYBRID & RESCUE INTRA-AORTIC BALLOON PUMP
  • Modelo / Serial
    Model Catalog: 0998-00-0800-XX (Lot serial: CA221162L2); Model Catalog: 0998-00-0800-XX (Lot serial: CA222640A3); Model Catalog: 0998-00-0800-XX (Lot serial: CA216325I2); Model Catalog: 0998-00-0800-XX (Lot serial: CA237421K3); Model Catalog: 0998-00-0800-XX (Lot serial: CA221164L2)
  • Descripción del producto
    MAQUET CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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