Events

Recall of Compella Bariatric Bed System, Controllers and Air Surfaces

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Hill-Rom 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-00745-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00745-1
  • 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
    Hill-rom has become aware of a potential issue with some compella air supply units and air surfaces. the compella air supply unit has been prone to inadequate pressure, which prevents the surface from achieving required settings for weight-based pressure redistribution. this also prevents the low air loss feature from operating. in addition, within the low air loss surface, a hose in the foot section is prone to kinking, which can impact airflow to the topper and prevent the proper adjustment of the air bladders to relieve pressure.
  • Action
    A Hill-Rom representative will be contacting affected facilities to make arrangements for updating the affected capital Compella Air Supply Units and air surfaces. In the interim, Hill-Rom recommends customers to continue to use the product as they normally would. The mattress system will provide an alarm in the event the Compella Air Supply Unit or Air Surface does not operate properly. This action has been closed-out on 18/05/2017.

Device

Compella Bariatric Bed System, Controllers and Air Surfaces
  • Model / Serial
    Compella Bariatric Bed System, Controllers and Air SurfacesModel Number: P7800ACompella ControllersProduct Number: P7810AManufactured between 25 March 2015 to 11 December 2015Compella Air SurfacesProduct Number: P642AManufactured between 25 March 2015 to 25 September 2015ARTG Numbers: 239273, 239274
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd