Events

Recall of PS500 External Power Supply Unit used 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-00165-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-02-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00165-1
  • 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 batteries installed in the ps500 deplete much earlier than expected although the battery indicator showed a sufficiently charged battery. in some cases neither the “battery low” nor the “battery depleted” alarm was given, when the remaining battery capacity fell below 10%. available data indicates that the charged battery will last for at least 3 minutes. in case of a main power loss, this 3 minute battery back-up should typically be sufficient until the emergency main power supply is re-established.
  • Action
    Draeger is advising users to only use the affected device for transport if absolutely necessary and users should not rely on the battery status indicator. Draeger is recommending users have a breathing bag available for manual ventilation as per the Instructions for Use (IFU). Draeger is advising that if the power fail alarm occurs during transport, provide manual ventilation and immediately connect the ventilator to wall power to resume ventilation. Draeger is advising that the batteries on all affected devices will be replaced as an interim correction, until a permanent fix can be developed.

Device

PS500 External Power Supply Unit used with Dräger V Series Ventilators

Manufacturer

Draeger Medical Australia Pty Ltd