Events

Recall of Drager V Series Ventilator with the Optional PS500 battery 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-2015-RN-01150-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-11-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01150-1
  • 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
    This recall is due to the unexpected shortening of the optional ps500 battery on an iacs workstation critical care unit. the batteries were discharged early, even though the device was indicating an adequate battery state of charge. the devices generate a "battery low" alarm, followed by "battery flat". in exceptional cases, the "battery flat" alarm might be displayed too late, or not at all. after complete discharge of the batteries, the device correctly alerts to failure of the power supply by the auxiliary alarm (piezo, power failure alarm) in all cases. it has been discovered that the current design of the charging algorithm for the new ps500 batteries is not able to appropriately prevent premature battery ageing in all application scenarios.The unexpected loss of automatic ventilation functionality due to depleted battery requires immediate user intervention to prevent serious patient harm, including death. no patient injuries have been reported so far.
  • Action
    The sponsor Draeger is advising users not to use devices with the affected PS500 battery unit for patient transport until the firmware has been updated.

Device

Drager V Series Ventilator with the Optional PS500 battery Installed
  • Model / Serial
    Drager V Series Ventilator with the Optional PS500 battery InstalledAffected models:Infinity V500Babylog VN500Evita V300All serial numbers affectedARTG Numbers: 158739, 170141 and 92177
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd