Events

Recall of Compella Air Surfaces Bed System (220 - 240 V, 50 Hz), used in conjunction with International 220 - 240 V, 50 Hz Controllers

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-2017-RN-01388-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01388-1
  • 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 international (220 - 240 v, 50 hz) compella air surfaces. within the low air loss mattress, a hose in the foot section is prone to kinking and occluding air flow. this can result in heat rising and failure of the air compressor inside the compella controller. if the compressor fails, the controller can no longer function correctly to maintain air flow to the compella mattress, in which case the controller will alarm. to date, there have been no reported patient safety related complaints associated with this issue.
  • Action
    Hill-Rom is advising users that the affected systems will be corrected as a permanent fix. The systems can continue to be used until the correction has been completed.

Device

Compella Air Surfaces Bed System (220 - 240 V, 50 Hz), used in conjunction with International 220...
  • Model / Serial
    Compella Air Surfaces Bed System (220 - 240 V, 50 Hz), used in conjunction with International 220 - 240 V, 50 Hz ControllersSerial Numbers: CR600003 to CR604302 and CU200002 to CU200072Manufacturing date range is from March 2015 – March 2017 ARTG Numbers: 239273 and 239274
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd