Events

Recall of Sidhil Inspiration Cot

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Midmed 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-00345-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-05-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00345-1
  • 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
    Following a period during which an active child had been left unattended in a 9003 inspiration cot the child was found by a consultancy paediatrician with his top wrapped around his head with the clothing hanging from the cots latch mechanism. the child had lifted up the tubing/cable access latch, which is located on the top rail at the head or foot end of the cot and managed to get his sleeve caught on the latch. upon trying to free himself the child managed to free his arms but was left with his clothing wrapped around his head, with the clothing still being caught on the top of the cot via the latch. the child was freed and no injuries were sustained.
  • Action
    Midmed is replacing the cable access cot ends with standard cot ends for all cots not used in critical care/intensive care.

Device

Sidhil Inspiration Cot
  • Model / Serial
    Sidhil Inspiration CotProduct Code: 9003ARTG Number: 167177
  • Manufacturer
    Midmed Pty Ltd

Manufacturer

Midmed Pty Ltd