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Medical Devices / Postmarket Safety

TGA Issues Recall for ResMed Astral Ventilators

Aug. 31, 2016

Australia’s Therapeutic Goods Administration is recalling ResMed Astral 100 and Astral 150 ventilators due to an internal battery issue.

The ventilators provide support to patients with respiratory difficulties; they have an internal battery designed to deliver continuous power when AC power is disrupted or when a patient is mobile.

The internal battery is intended to provide power for up to eight hours under normal conditions. When a ventilator is being used with the internal battery as the sole power source, the ‘low battery’ alarm is designed to activate when there are 20 minutes of ventilation time remaining and the ‘critically low battery’ alarm is designed to activate when there are 10 minutes of ventilation time remaining.

ResMed has received a number of reports of the ventilation stopping without either the ‘low battery’ or ‘critically low battery’ alarms activating. The risk of this occurring is increased if the internal battery has been charged a high number of times. — Tamra Sami

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