Events

Recall of Optional PS500 External Power Supply Unit Used in connection with Dräger V Series Ventilators

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-2014-RN-00989-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-09-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00989-1
  • 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
    Draeger has advised that in some cases in which the battery capacity of the optional ps500 power supply unity of the infinity acs workstation critical care (evita infinity v500) has reduced unexpectedly. the batteries in the ps500 were discharged prematurely, even though adequate battery charge status was displayed on the device. as a consequence of this, draeger published a safety alert in february 2014, as well as a safety recall and the suspension of deliveries for devices using the ps500.
  • Action
    All PS500 Power Supply Units currently in use are in the process of being upgraded by the Dräger Service Engineers free of charge. A service-charging algorithm will be implemented, which prevents the problem of sulfation of the batteries, which was identified as a main reason for the reduction of the PS500 battery capacity.

Device

Optional PS500 External Power Supply Unit Used in connection with Dräger V Series Ventilators

Manufacturer

Draeger Medical Australia Pty Ltd