Events

Recall of Entroy Pool Lifter

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Arjo Australia 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-2018-RN-00230-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-03-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00230-1
  • 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
    Arjo have identified a potential for the chair or stretcher detachment from entroy pool lifter. it is identified that this issue is caused by a potential misalignment that might be unnoticed by the caregiver so the seat/stretcher does not get fully paired with the pin. instead, once the lift reaches certain height, the seat/stretcher falls off the lift. there are one or more possible reasons that can lead to such a situation to occur: - maintenance checks not performed properly,- users do not recognize the poor connection,- pool lift owners does not recognise that the product needs maintenance, - wear on the docking connection causes the pin to hit the edge of the pairing cylinder instead of entering it.
  • Action
    Arjo are advising users that they will arrange for an on-site service technician visit to install a Quick Reference Guide, which is an illustration-based instruction, which users may refer to ensure a patient transfer is conducted as indicated in the IFU.

Device

Entroy Pool Lifter
  • Model / Serial
    Entroy Pool LifterModel Number: GAB1000-x01Affected Serial Numbers 810000957 up to T3387 ARTG: 230595Arjo Australia - Lift, patient transfer, stationary
  • Manufacturer
    Arjo Australia Pty Ltd

Manufacturer

Arjo Australia Pty Ltd
  • Source
    DHTGA