| 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 |
|
| 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 |