Recall Z-1750-2015 ยท CBK Ventilator, Continuous, Facility Use
ResMed Ltd.
Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
| Date | Jun 10, 2015 (initiated May 5, 2015) |
| Status | Terminated |
| Reason | The Astral device allows clinicians to disable all alarms including those that detect circuit disconnection. Inappropriate disabling of alarms in ventilator dependent patients can lead to hazards of insufficient ventilation and insufficient expiratory pressure which can result in major severity harm. |
| Root cause | Use error |
| Action | A customer notification letter dated 5/5/15 will be sent to customers that the Astral device allows clinicians to disable all alarms including those that detect circuit disconnection. The letter provides the customers with the hazards involved and the actions to be taken. Customers are instructed to ensure alarms are appropriately set up for ventilator dependent patients. Customers with questions are instructed to contact Larissa D'Andrea at (858) 836-6837 or email larissa.d'andrea@resmed.com. |
| Quantity | 1519 units |
| Distribution | Worldwide distribution. US nationwide, Uruguay and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133868 | ASTRAL VENTILATOR Resmed, Ltd., Jun 4, 2014 |