Events

Recall of Device Recall Emergency Transport Ventilator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Draeger Medical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72914
  • Event Risk Class
    Class 1
  • Event Number
    Z-0691-2016
  • Event Initiated Date
    2015-12-22
  • Event Date Posted
    2016-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142495
  • Notes / Alerts
    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.
  • Extra notes in the data
    Ventilator, continuous, facility use - Product Code CBK
  • Reason
    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.
  • Action
    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
  • Model / Serial
    All Oxylog 2000 plus Ventilators with the identified catalog numbers distributed between April 2007 - December 2015.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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.
  • Manufacturer Address
    Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • Manufacturer Parent Company (2017)
    Stefan Dräger GmbH
  • Source
    USFDA