Events

Retiro De Equipo (Recall) de SJM CONFIRM EXTERNAL PATIENT ACTIVATOR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ABBOTT MEDICAL CANADA 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
    56049
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-03-18
  • 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
    Faster than normal battery depletion was identified in 2 lots of batteries used to power handheld sjm confirm external patient activator (dm2100a). the affected activators may exhibit faster than normal low battery status (one low-pitched tone and flashing red lights for 9-10 seconds once every hour or immediately when a button is pressed) or complete battery depletion (silent and no flashing lights) if the audible and visible alerts are ignored.

Device

SJM CONFIRM EXTERNAL PATIENT ACTIVATOR
  • Modelo / Serial
    Model Catalog: DM2100A (Lot serial: AFFECTED LOT NUMBERS ARE NOT); Model Catalog: DM2100A (Lot serial: VISITBLE TO THE USER AS THEY); Model Catalog: DM2100A (Lot serial: ARE ON THE BATTERY INSIDE THE); Model Catalog: DM2100A (Lot serial: ACTIVATOR. CONTACT MFR.)
  • Descripción del producto
    SJM CONFIRM EXTERNAL PATIENT ACTIVATOR
  • Manufacturer
    ABBOTT MEDICAL CANADA INC.

Manufacturer

ABBOTT MEDICAL CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    HC