Events

Recall of Drager V Series Ventilator with the Optional PS500 External Power Supply Unit installed

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Draeger Medical Australia Pty Ltd.

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
    RC-2017-RN-00176-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-02-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00176-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Dräger became aware that the battery capacity of the optional ps500 power supply unit was unexpectedly reduced. this resulted in batteries prematurely discharging, even though an adequate battery charge status was displayed. the "battery discharged" alarm was not in all cases triggered five minutes prior to battery discharge, as specified. when the batteries were completely discharged, the devices triggered the existing power failure alarm correctly. the reported issue may cause unexpected loss of automatic ventilation functionality.Further to the recall for product correction in feb 2016 (tga ref.: rc-2016-rn-00154-1), dräger has now developed device modifications to rectify the issue.
  • Action
    The device modifications include the following:  - Installation of a new software 2.50 with improved battery charge management  - Improved charge management for external batteries  - Option of performing a battery check to determine the battery's current runtime  - Option of displaying the remaining battery capacity in minutes  - Installation of an additional internal backup battery  - Replacement of the power supply unit to support both the external battery and an additional internal battery  - Replacement of the existing external batteries. The installation of a backup battery will ensure that the internal battery will continue to supply power should the external battery fail. Users are advised to continue to observe the information in the Feb 2016 letter until the devices have been updated with the improved system.

Device

Drager V Series Ventilator with the Optional PS500 External Power Supply Unit installed
  • Model / Serial
    Drager V Series Ventilator with the Optional PS500 External Power Supply Unit installedAffected Models: Infinity V500; Evita V300; and Babylog VN500 All Serial Numbers affectedARTG Numbers: 158739, 170141 and 92177
  • Product Classification
    Anesthesiology Devices
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd