Events

Alerta De Seguridad para OXYLOG 3000 URGENT FAN AND TRANSPORTATION FAN. Registro ANVISA: 10407370059. Products affected: Only equipment with software version 1.10 (delivered or updated as of February 2008). Serial numbers with software version 1.10: SRZA-0182 and above 0182; SRZB-xxxx; SRZC-xxxx; SRZD-xxxx; SRZE-xxxx; SRZF-xxxx; SRZH-xxxx; SRZJ-xxxx. Note: xxxx means from 0001 to 9999.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por DRÄGER INDÚSTRIA E COMERCIO LTDA..

¿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
    950
  • Fecha
    2008-12-01
  • 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
    Software version 1.10 was pre-installed on all new OXYLOG 3000 devices delivered by Dräger from February 2008. As of this date, software version 1.10 was also available as an Update Kit for equipment. The company informed UTVIG / Anvisa that it is already developing new software for the correction of the problem, which should be made available until December 31, 2008. The notification form of the problem to UTVIG / Anvisa is available at http: // www .anvisa.gov.br / tecnovigilancia / alerts / annexes_2008 / 950_notifica.pdf. For more information on the problem, please refer to the appendixes to this alert.
  • Causa
    Under certain conditions, ventilation of affected equipment can be interrupted for approximately 5 seconds.
  • Acción
    According to the holder of the product registration, a Safety Letter has already been sent to the Customers http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/950_carta.pdf). In addition, the company has informed that it has already sent a technical bulletin (TSB n ° 15) to all the companies responsible for the product marketing / technical assistance. (1) Immediately check if there are any affected products in your inventory, given the serial number on the back of the equipment (the serial numbers described in the Product Description field); (2) If the serial number is not listed in the list above, check the version of the software installed on the device (when connecting the OXYLOG 3000, the software version is displayed on the screen); (3) If the product is found to be affected, notify the product registration holder as soon as possible (see address in the Manufacturer's description field), informing your data and the serial number (s) of the s) equipment (s) at identified risk (s); (4) Quickly replace, if possible, equipment affected by another lung ventilator, identifying and segregating the ventilator at risk to avoid inadvertent use of the ventilator; (5) If replacement by other equipment is not possible, alert the persons involved in the operation of the equipment (nurses, doctors, etc.) to the risk associated with the equipment, leaving, if possible, a written warning on the equipment under risk; (6) Until the equipment at risk is replaced / updated by the registry holder, always keep an alternate source of ventilation (eg a manual ventilation flask) which can be used quickly in case of failure .

Device

OXYLOG 3000 URGENT FAN AND TRANSPORTATION FAN. Registro ANVISA: 10407370059. Products affected: O...

Manufacturer

DRÄGER INDÚSTRIA E COMERCIO LTDA.