Events

Recall of Bunnell Life Pulse Patient Circuits (Used with Life Pulse High Frequency Ventilator) Manufactured after 19-12-2012

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by AHC Solutions 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-2012-RN-01190-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-01-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01190-1
  • 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 heater wire insulation can melt, causing a short which creates sparking and smoke close to the humidifier cartridge.
  • Action
    Unaffected replacement circuits are not available at this time. Each user should consider the likelihood and severity of the potential risks of using the affected circuits, as well as the medical necessity of using High Frequency “Jet” Ventilation, to determine whether it would be in their patients’ best interests to use the affected circuits or not. If users have other options for High Frequency “Jet” Ventilation, the affected units can be returned to AHC Solutions for credit to be issued.

Device

Bunnell Life Pulse Patient Circuits (Used with Life Pulse High Frequency Ventilator) Manufactured...
  • Model / Serial
    Bunnell Life Pulse Patient Circuits (Used with Life Pulse High Frequency Ventilator) Manufactured after 19-12-2012 Lot Numbers: 12C092, 12E211, 12H330, 12C102, 12E224, 12H349, 12C115, 12F241, 12I362, 12C125, 12F254, 12I371, 12C136, 12F271, 12I397, 12D159, 12G279, 12J413, 12D172, 12G290, 12J430, 12D189, 12G307, 12J448, 12E204, 12G321, 12K457, 12K471ARTG number for the Ventilator: 179402
  • Product Classification
    Anesthesiology Devices
  • Manufacturer
    AHC Solutions Pty Ltd

Manufacturer

AHC Solutions Pty Ltd