Field Safety Notification (FSN1608002)
This notification addresses an internal electrical issue with the Astral 100 and Astral 150 ventilators that may cause ventilation to cease without alarm activation.
The issue, which affects the internal battery, has been reported in less than 0.1% of devices sold. Although no adverse health effects have been reported, ventilator-dependent patients may be at risk if no urgent action is taken to restore power or switch to back-up ventilation.
Actions Required
Healthcare providers and distributors must take immediate action to replace the battery packs and follow precautions to ensure patient safety.
Patients should be contacted to arrange battery pack replacement, and replacement should occur within six months for ventilator-dependent patients and within twelve months for all other devices.
Precautions
Users and carers must connect the ventilator to AC power whenever possible, use an external power source for ventilator-dependent patients, and ensure the external battery is sufficiently charged before use in mobile situations.
Ventilator-dependent patients should always have alternate ventilation equipment available and be continuously monitored by qualified personnel or trained carers.
Manual:
Download: Astral 100 and Astral 150 Ventilators Field Safety Notification User Manual
Chat: Powered By VoiceSphere