Events

Retiro De Equipo (Recall) de ON-Q C-BLOC

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MEDQUEST MEDICAL 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
    82530
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2012-06-22
  • 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
    I-flow recently determined that in a small quantity of on-q pumps with ondemand the bolus button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowermost position. in this condition the patient may receive continuous infusion at a rate greater than expected.

Device

ON-Q C-BLOC
  • Modelo / Serial
    Model Catalog: CB003 (Lot serial: Products having a 10-digit); Model Catalog: CB006 (Lot serial: are NOT impacted by this); Model Catalog: CB003 (Lot serial: lot#s that is >0200521454); Model Catalog: CB006 (Lot serial: lot#s that is >0200521454); Model Catalog: CB003 (Lot serial: (ie. 0200521455 and greater)); Model Catalog: CB006 (Lot serial: Products having a 10-digit); Model Catalog: CB003 (Lot serial: recall.); Model Catalog: CB006 (Lot serial: recall.); Model Catalog: CB003 (Lot serial: are NOT impacted by this); Model Catalog: CB006 (Lot serial: (ie. 0200521455 and greater))
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Descripción del producto
    ON Q C-BLOC WITH ONDEMAND (MODEL # CB003 & MODEL # CB006)
  • Manufacturer
    MEDQUEST MEDICAL INC.

Manufacturer

MEDQUEST MEDICAL INC.