FDA Recall: Draeger Medical Unexpected Depleted Battery

Recalled Product

  • Product Names: Oxylog 3000 Plus Emergency and Transport Ventilator
  • Part Numbers: 5704811 and 5704813
  • Product Material Numbers: See Recall Database Entry
  • Distribution Dates: April 30, 2012 to June 13, 2022
  • Devices Recalled in the U.S.: 300
  • Date Initiated by Firm: June 12, 2023

Device Use

The Oxylog 3000 Plus Emergency and Transport Ventilator is used for people who require full or partial breathing assistance from a mechanical ventilator. Healthcare professionals use it during patient transport, either in an ambulance or aircraft or to move people using ventilators throughout the hospital and recovery room.

Reason for Recall

Draeger Medical is recalling the Oxylog 3000 Plus Emergency and Transport Ventilator after receiving reports that the device stopped ventilation because of a depleted battery, even after being re-connected to AC power. The ventilator may not automatically switch back to using AC power when it is plugged in and may continue using the battery until it is depleted, then stop providing ventilation. A battery alarm: “Charge int. battery” and “Int. battery discharged” does occur with this issue.

Stopped ventilation may cause difficulty breathing (respiratory distress), lack of oxygen (hypoxia), slow heartbeat (bradycardia), a sudden stop of the heart (cardiopulmonary arrest), other severe injuries, or death.

Draeger Medical reports six complaints, no injuries, and no deaths related to this issue.

Who May be Affected

  • People who receive breathing support from the Oxylog 3000 Plus Emergency and Transport Ventilator
  • Health care providers who provide breathing support care for patients with Oxylog 3000 plus Emergency and Transport Ventilator

What to Do

In June 2023, Draeger Medical sent affected customers an Urgent Medical Device Recall letter with the following recommendations:

  • Make sure that the battery is always removed and reinserted or replaced after an occurrence of the “No int. battery charging” alarm message without removing the device from main power supply.
  • Ensure the correct switchover by disconnecting and then reconnecting the device to an AC main power supply before using the device on battery power. Indicator A should display a green light, and indicator B should display a green or yellow light.
Diagram of Oxylog 3000 plus with labeled arrows for indicator lights A and B.
  • If indicator B displays a red light, you should disconnect and reconnect or replace the battery.
  • Devices can continue to be used safely as long as the precautions and actions above are taken.
  • Ensure that all users and maintenance personnel of the products within the organization are made aware of the recall notice.
  • Forward a copy of this information if products were provided to third parties.
  • Complete and return the Customer Acknowledgment Card attached to the letter to confirm the information was received.
  • Keep this information available until update measures have been completed.
  • Contact Draeger Service Technical Support with questions about the operation of the Oxylog 3000 plus: Technical Support 1-800-437-2437, press 2 at the prompt, then 2, then 1, between the hours of 8 a.m. and 8 p.m. EST.

The letter also states that a local Draeger service representative will contact customers to arrange for a firmware update of the Printed Board Assembly Charger.

About the author

Hello, I'm Patricia Jones, a dedicated marketing professional with a passion for making impactful connections between brands and their audiences. As a marketing enthusiast, I've had the privilege of working on diverse campaigns across various industries, gaining valuable insights into consumer behavior and market trends. when I'm not crafting marketing magic, you can find me exploring new cuisines, unwinding with good Bodypump session or supporting local communities initiatives.

SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  June 5-7, 2024
Boston, MA

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

Registration Link:

Register Now



Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: February 12-15, 2024

Virtual via Zoom

Registration Link:

Register Now



Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

Corporate Office

15148 Springview St.
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN, TX) and Canada.