| Originator: |
|
National Patient Safety Alert - MHRA
|
 |
|
|
- Care Trusts
- Mental Health Trusts
- Specialists Trusts
- Learning Disabilities Trusts
- Mental Health & Social Care Trusts
- Ambulance Trusts
- Mental Health & Learning Disabilities Trusts
- Acute Trusts
- Community Trusts
|
|
|
- Other contacts
- Independent Healthcare Providers (registered with CAS)
- Clinical Commissioning Groups
- NHS Regional Offices
- Social Care Providers (registered with CAS)
- Special Health Authorities
- Territorial CMOs in Northern Ireland, Scotland & Wales
- Integrated Care Boards
|
| Title: |
|
ResMed Astral 100 and 150 Ventilators: Potential for Patient Harm due to Unexpected Interruption of Ventilation Therapy
|
| Broadcast content: |
|
ResMed has issued a Field Safety Notice (FSN)
regarding Astral 100 and 150 ventilators and
associated Printed Circuit Board Assembly (PCBA)
spare parts manufactured prior to October 2024. An
internal supercapacitor may leak electrolyte,
causing damage to specific circuitry of the PCBA
and unexpected interruption of ventilation therapy.
If the issue occurs while the ventilator is delivering
therapy, ventilation therapy stops immediately; a
high priority audible alarm activates, and the user
interface may display therapy alarms and a Safety
System Fault red screen. If the issue occurs while
the device is in standby, a maximum volume alarm
activates, and the user interface message may not
be displayed. Once the fault occurs, the ventilator
becomes inoperable and cannot be restarted.
Alternative ventilation is required immediately.
Astral ventilators are used in hospital, community
and home settings to provide life-sustaining
ventilation for adults and children, including
tracheostomy-ventilated, ventilator-dependent and
mouthpiece-ventilated patients. Although the
reported occurrence rate is low at 0.1% over the
device service life of 8 years, interruption of
ventilation may result in serious injury or death if an
alternative means of ventilation is not immediately
available.
Replacement PCBAs are currently subject to global
supply constraints. ResMed cannot currently provide a definitive timeline for completion of
corrective actions across all affected devices.
Therefore, available replacements are being
prioritised for patients according to highest clinical
risk.
Organisations experiencing difficulty obtaining
suitable replacement or alternative ventilators
should escalate through local procurement
arrangements and the DHSC National Supply
Disruption Response (NSDR) service where
appropriate at: nsdr@dhsc.gov.uk. This National Patient Safety Alert provides further background, clinical information and actions for providers.
|
| Additional information: |
|
This Alert is not relevant to Primary Care
|
| Action underway deadline: |
|
19-Aug-2026
|
| Action complete deadline: |
|
17-Feb-2027
|