Events

Retiro De Equipo (Recall) de THERMOPHORE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BATTLE CREEK EQUIPMENT.

¿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
    140634
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-11-03
  • 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
    The issue was that the product fails prematurely when misused. the failure is specifically in the area where the electric cord meets the strain relief/switch. in cases where a user repeatedly bends and stresses the cord at a sharp/tight angle the cord may wear leading to a quick spark when the wire inside the cord fails. this then may lead to a visible spark small amounts of smoke or small amounts of carbon residue when it fails. the failure does not have any likelihood of injuring the user. this failure mode has been seen in less than one-hundredth of one percent (.09%) of units in the field.

Device

THERMOPHORE
  • Modelo / Serial
    Model Catalog: 095 (Lot serial: NA); Model Catalog: 096 (Lot serial: NA); Model Catalog: 097 (Lot serial: NA)
  • Descripción del producto
    THERMOPHORE
  • Manufacturer
    BATTLE CREEK EQUIPMENT

Manufacturer

BATTLE CREEK EQUIPMENT