Events

Recall of Drager V Series Ventilator with the Optional PS500 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-2016-RN-00154-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-02-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00154-1
  • 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
    The battery capacity of the optional ps500 power supply unit for the evita infinity v500, evita infinity v300 and the babylog vn500 rapidly and unexpectedly reduces despite using the most recent power supply firmware (fw1 .50) which was released in november 2015 .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 which could lead to serious injuries to the patient. so far no injuries have been reported.
  • Action
    The sponsor is cancelling the distribution of the updated power supply firmware (FW1.50) and rolling back devices on which this firmware version is already installed to FW1.49. As a preventive measure, Dräger will replace the batteries of all PS500 customers every 6 months until a permanent technical solution is available. Dräger is also advising users NOT to use the device for patient transport unless absolutely necessary and NOT to rely on the battery status indicator.

Device

Drager V Series Ventilator with the Optional PS500 Installed
  • Model / Serial
    Drager V Series Ventilator with the Optional PS500 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