Hamilton Medical G5 / S1 Ventilator with software version V2.42 의 리콜

Recall

RC-2016-RN-00285-1

Class II

2016-03-15

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00285-1

Investigations have shown that after performing the suctioning manoeuvre, including disconnecting the patient, suctioning and reconnecting the patient, the present pattern of ventilation may not continue as expected due to a software issue. under certain conditions, a different ventilation mode than the operator selected mode may be applied. this situation can occur independent from the selected patient group (neonate, paediatric or adult). if the ventilator’s incorrect behaviour is not detected, the patient is ventilated with the ventilation mode active prior to the pre-oxygenation phase. in the worst case, the patient may be either hypo ventilated or hyperventilated.

The sponsor Taleb is advising customers that a software update (v 2.60) will be installed on all affected units by June/July 2016. As an interim measure, the sponsor will permanently disable the automated suctioning manoeuvre functionality on all affected units. In addition, the operator must verify that the ventilation continues after a suctioning manoeuvre is finished. If the ventilation does not continue as expected, one of the following options can be used to re-establish ventilation as set: • Press the “Manual Breath” key on the ventilator’s front panel. • Select a different ventilation mode. • Switch to the “Standby mode” and return to the previously used ventilation mode. This action has been closed-out on 09/05/2017.