Events

Retiro De Equipo (Recall) de Carina Ventilator

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Draeger Medical, 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
    80027
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1954-2018
  • Fecha de inicio del evento
    2018-04-26
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164234
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Ventilator, continuous, facility use - Product Code CBK
  • Causa
    The valve assembly material may become corroded due to insufficient cleaning by a supplier. there is a risk of the breathing gas becoming contaminated in the affected devices.
  • Acción
    On April 27, 2018, the recalling firm contacted its consignees by telephone prior to sending out Urgent Medical Device Recall notifications via e-mail. Customers were instructed to remove affected devices from operation immediately. The firm provided replacement devices so customers could send their affected ventilator to the firm's repair center for update once the required parts were available. Customers were also asked to inform all affected users at each site. If you have any questions regarding this letter please contact Michael Kelhart between the hours of 8:00 AM  4:30 PM EST at 1-800-437-2437. For questions regarding the operation and/or servicing of your Carina Ventilator please contact Dr¿ger Service Technical Support between the hours of 8:00 AM  8:00 PM EST at 1-800-437-2437.

Device

Carina Ventilator
  • Modelo / Serial
    Serial nos. ASKM-0065 ASKM-0066 ASKM-0106 ASKM-0134 ASKM-0137 ASKM-0150 ASKM-0151 ASKN-0009
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed to the states of CT, IL, MN, NV, SD, and WA.
  • Descripción del producto
    Carina Ventilator, ventilator. Catalog no. 5704110. || Long-term ventilator for treatment in hospitals by a qualified medical personnel.
  • Manufacturer
    Draeger Medical, Inc.

Manufacturer

Draeger Medical, Inc.
  • Dirección del fabricante
    Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • Empresa matriz del fabricante (2017)
    Stefan Dräger GmbH
  • Source
    USFDA