Events

Recall of Affinity Four Birthing Bed

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-2014-RN-00713-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00713-1
  • 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 would like to remind users of proper handling of the lift-off foot section per the affinity four birthing bed manual. improper handling, such as allowing the foot section to be dropped repeatedly, could cause the attachment latch mechanism to become bent. if the latch mechanism is bent badly enough, it could potentially cause the installed foot section to be improperly engaged onto the bed. if the damaged foot section should disengage during use, this could result in injury to the user due to a fall.
  • Action
    Hill-Rom is highlighting key instructions in the operator's manual and providing additional instructions to end users to verify if the Lift-Off foot sections have enough engagement. A change to the Lift-Off foot section is currently in development to mitigate the issue.

Device

Affinity Four Birthing Bed
  • Model / Serial
    Affinity Four Birthing Bed Part Number: (P3700B/C/D/E)Production dates: October 2006 through June 2014ARTG Number: 151145
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd