Recall of Hamilton Medical G5 / S1 Ventilator, software versions between V2.00 and V2.31

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia.

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-00557-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-05-28
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • 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
    Investigations have shown that ventilation and alarms of a hamilton g5 or hamilton s1 ventilator can be suppressed unintentionally after the activation of a suctioning manoeuvre by the operator. this situation can occur regardless of the selected patient group (neonatal, paediatric, & adult). this vulnerability of the hamilton –g5 and hamilton –s1 exists under specific conditions within an interface prone time window of 50 milliseconds after the ventilator detects a disconnection during a suctioning manoeuvre that has been initiated by operator pressing the o2-enrichment key on the ventilator. this issue could result in the termination of mechanical ventilation and suppression of alarms with the exception of the medium-priority alarm “loss of peep” when peep is set > 4 mbar. please note that the ambient and exhalation valves of the ventilator are opened so that a spontaneously breathing patient can breathe room air unassisted by the ventilator.
  • Action
    Permanently disable the automated suctioning manoeuvre functionality on all Hamilton G5/ Hamilton S1 ventilators by using a software key provided by the manufacturer. This correction will be undertaken during the preventative maintenance due in June/July 2014. Thia action has been closed-out on 28/01/2016

Device