Events

Alerta De Seguridad para Magnetic Resonance Imaging System, Model: DISCOVERY MR450 - Registration 80071260116 - Serial Numbers: This correction applies to all GE Healthcare magnetic resonance imaging (MRI) systems with superconducting magnets.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médicos-Hospitalares Ltda.; GE MEDICAL SYSTEMS, LLC.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1501
  • Fecha
    2015-01-26
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
    The company informs that the Magnetic Field Deactivation Module (MRU) is a fundamental safety component of the magnetic resonance (MR) system that generates the magneto quench (ie, causes it to become non- magnetic) in emergency situations, such as may occur when a ferromagnetic object is brought into the magnetic field.
  • Causa
    The company informs that there is a possibility that the mru is not connected to the magnet. if the mru is turned off, it will not work as expected and will not generate the quench on the magnet when the button is pressed. in emergencies, the disconnected mru could delay the removal of a ferromagnetic object from the magnet, potentially resulting in serious injuries.
  • Acción
    As a precautionary measure, users should confirm that the MRU is connected to the magnet by performing the following four-step test in the MRU: 1. Verify that the green Charger Power LED is lit. 2. Press and hold the BATTERY TEST button (Test Battery) for 15 seconds. The green BATTERY TEST LED should light up and remain lit while the BATTERY TEST button is pressed. 3. Set the HEATER TEST switch (Test Heater) to position A. The green HEATER TEST LED should light up. If it does not light up, press the HEAT TEST LED (Test Heater LED) button to verify that the LED is working. 4. Set the HEATER TEST switch to position B. The green HEATER TEST LED should light up. If it does not light up, press the HEATING LED TEST button to verify that the LED is working. If the MRU test does not work as described in each of the 4 steps above, users should stop using the system and call the GE Healthcare representative immediately for correction. Users should also refer to the Safety Manual for precautions regarding the handling of ferromagnetic material around high magnetic fields. Users should be familiar with routine inspections and maintenance of the safety features of the system and the various methods that can be used if magnetic field quench is required. All of this information is documented in the Safety Manual provided with the MRI (Magnetic Resonance Imaging) system.

Device

Magnetic Resonance Imaging System, Model: DISCOVERY MR450 - Registration 80071260116 - Serial Num...

Manufacturer

GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médicos-Hospitalares Ltda.; GE MEDICAL SY...