| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00556-1 |
| Product Name/Description |
HAMILTON G5 / S1 ICU ventilators
Software versions 2.00X up to 2.31X |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
29/05/2014 |
| 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 maneuver by the operator; this situation can occur regardless of the selected patient group (neonatal, pediatric and adult). This vulnerability of the HAMILTON-G5 and HAMILTON-S1 exists within an interference-prone time window of 50 milliseconds after the ventilator detects a disconnection during a suctioning maneuver that has been initiated by the operator pressing the O2-enrichment key on the ventilator. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
AHC Solutions is advising operators to always verify that ventilation continues after a suctioning manoeuvre. If ventilation does not continue it can be re-established by pressing the "Manual Breath" key, change the ventilation mode and switch to the "Stand-by Mode" and return to the previously used ventilation mode. AHC Solutionsis advising customer to permanently disable the automated suctioning manoeuvre on all affected ventilators using the software key provided with the customer letter to avoid the issue from occurring. This action has been closed-out on 29/01/2016. |
| Contact Information |
02 9980 9669 - AHC Solutions |