Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00557-1
Product Name/Description Hamilton Medical G5 / S1 Ventilator, software versions between V2.00 and V2.31

Serial Numbers: 7198, 7216

ARTG Number:194271
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 28/05/2014
Responsible Entity The Trustee for the Taleb Family Trust T/A Taleb Medical and Vetequip Australia
Reason/Issue 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.
Recall Action Recall for Product Correction
Recall Action Instructions 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
Contact Information 03 9330 4940 - Taleb Medical