Events

Alerta De Seguridad para Model: T2100, Brand: GE Healthcare, Register: 80071260189, Equipment Affected: All treadmills T2100

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 Médico-Hospitalares Ltda.; GE Medical Systems Information Technologies, INC..

¿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
    1545
  • Fecha
    2015-03-18
  • 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 registry holder informs that the occurrence of the failure can generate a sudden change in speed and / or direction of the treadmill, with possibility of falls and injuries in patients. The risk of movement of the canvas increases on the larger inclines of the treadmill. ### Update of the field action: UPDATED ON 10/23/2017, the company presented the report of completion of the field action proving the sending of the safety notice to the client with evidence of science and all actions completed.
  • Causa
    Treadmill performance failure due to loss of commutation (required for proper motor operation), which can cause uncontrolled movement of the canvas during a stress test exercise. this movement can be observed as an unexpected deceleration, followed by a sudden acceleration of the canvas, forward or backward. when this occurs, the treadmill will not stop immediately after pressing the emergency stop button (estop).
  • Acción
    According to the record holder, "if any uncontrolled movement of the tarpaulin, including unexpected stop, deceleration, acceleration or change of direction, is observed while the patient is on the treadmill, the health professional should: • Press the Stop button • Instruct the patient to: - Hold the handrails to help maintain balance - Exit the canvas by placing the feet on the non-slip rubberized sides that are on the sides of the canvas - After the treadmill stops instruct the patient to get off the treadmill. Depending on the speed of the canvas, a complete shutdown can take up to 35 seconds. • If any uncontrolled treadmill movement is observed, discontinue use of the T2100 treadmill and contact GE Healthcare.

Device

Model: T2100, Brand: GE Healthcare, Register: 80071260189, Equipment Affected: All treadmills T2100

Manufacturer

GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; GE Medical Sys...