Events

Alerta De Seguridad para Intensive Care Ventilator Engstrom Carestation, Risk Class III, Model: Engstrom Carestation and Engstrom Pro, Brand: GE Healthcare, Registered: 80071260230, Serial Number: Engstrom CBCN01062 to CBCQ01396 (SEE APPENDIX). Accessory trolleys sold separately from Engstrom fans are also affected from October 2009 to September 2011.

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; DATEX-OHMEDA 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
    1519
  • Fecha
    2015-02-04
  • 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
    According to the record holder, failure of the caster assembly equipment may result in fan drop / tilt (imbalance).
  • Causa
    The company informs that specific combinations of engstrom fan casters and bases have been identified that are more likely to fail the caster mounting equipment. failure of the caster mounting equipment may result in fan dropping / tilting (imbalance). a fall / tilt of the engstrom fan may result in serious injury to patients or clinic staff.
  • Acción
    GE Healthcare of Brazil makes it clear that customers can continue to use the Engstrom fan equipment. If the fan equipment is mounted on a cart, make sure that the carriage assembly is fully tightened and shows no signs of damage. If there are signs of damage, contact the GE Healthcare service or your local service representative. GE Healthcare will fix all affected systems at no cost to the customer. A GE Healthcare Technical Services representative will contact you to perform this fix. (SEE CUSTOMER LETTER)

Device

Intensive Care Ventilator Engstrom Carestation, Risk Class III, Model: Engstrom Carestation and E...

Manufacturer

GE Healthcare do Brasil; DATEX-OHMEDA Inc.