Events

Retiro De Equipo (Recall) de Device Recall Emergency Transport 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
    72914
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0691-2016
  • Fecha de inicio del evento
    2015-12-22
  • Fecha de publicación del evento
    2016-02-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142495
  • 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
    Drager became aware of situations where the error message "poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating.
  • Acción
    The firm, Draeger Medical, Inc., sent an "Urgent Medical Device Recall" letter dated 12/21/2015 and a copy of the Instructions for Use (IFU) Supplement to consignees in a method that confirms delivery. The letter described the product, problem and actions to be taken. The consignees were instructed to include a copy of the supplement with their Oxylog IFU; inform all affected users in their facility; and contact Draeger Customer Support at 1-800-543-5047 (press 4 at the prompt) to obtain additional copies of the IFU Supplement Free of Charge. If there are any questions regarding this letter, please contact Michael Kelhart at 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of your Dr¿ger Oxylog ventilator please contact Dr¿gerService Technical Support at 1-800-543-5047 (press 4 at the prompt). On 12/09/2016, Draeger mailed an Urgent Medical Device Recall notification letter to affected customers to inform them of a revised new software for the Oxlog 3000/3000plus (version 1.06 for Oxylog 3000 plus and version 1.23 for Oxylog 3000) that reduces the impact of the error condition. Customers will be contacted by a Drager Service Representative to schedule a time to perform the software update free of charge. The new software changes the device behavior in the event of the error (a controller failure). With the new software, in the event of a controller failure, ventilation will not stop. The device will continue to ventilate with the last setting. An alarm will annunciate and be displayed, alerting the user of the controller failure.

Device

Device Recall Emergency Transport Ventilator
  • Modelo / Serial
    All Oxylog 2000 plus Ventilators with the identified catalog numbers distributed between April 2007 - December 2015.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- including states of AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
  • Descripción del producto
    Emergency Transport Ventilator || Oxylog 2000 Plus Ventilator || Catalog Number: 5705080. || Volume controlled emergency and transport ventilator with pressure support.
  • 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