Events

Recall of Monitor AC3000 Spring Arm (component of Draeger ceiling pendant and light systems)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Draeger Medical 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-2013-RN-01239-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-11-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01239-1
  • 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
    The manufacturer has become aware of a case in which the monitor support bracket has detached from the joint pin at the bottom of the height adjustable ac3000 spring arm and fallen down together with the monitor until it was only held by the electrical cable connections. an inspection of a further seven monitor brackets in the same hospital identified severe wear on the ring groove responsible for the joint pin. investigation showed that the support shoulder of the locking element in the aluminum pin's groove is too low in an unfavorable tolerance position. the frequent movement of the arm under load may cause the locking element to damage the pin's groove and ultimately shear off, which may then result in the reported event.
  • Action
    Drager is advising users that the monitor arms will be inspected and repaired if required. Drager is also providing instructions to be followed by technically trained personnel, and will provide the required locking elements for replacement.

Device

Monitor AC3000 Spring Arm (component of Draeger ceiling pendant and light systems)
  • Model / Serial
    Monitor AC3000 Spring Arm (component of Draeger ceiling pendant and light systems)Part Numbers: G92756 and G94499ARTG Number: 132260
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd