Event Medical Recalls Inspiration Ventilators Due to Power Board Failure
Event Medical is recalling Inspiration Ventilator Systems because a power board component can fail, causing the device to shut down without an alarm.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric. Additionally, the failure mode (silent shutdown of a life-support device) poses a significant risk of serious injury.
Plain-English summary
Event Medical LTD is recalling the Inspiration Ventilator System, i Series and LS 12.1 LCD, including the Inspiration 7i / 5i Ventilator System. These devices are intended for use by healthcare professionals in hospitals, healthcare facilities, and during intra-hospital transport.
The recall is due to a defect in a component on the system's power board. This component can fail in a manner that causes the ventilator to shut down without triggering an alarm. All models manufactured prior to 2015 are affected by this issue.
A total of 6,441 units are involved in this recall, with 251 units distributed in the United States. The remaining units were distributed internationally to numerous countries. Healthcare facilities should contact Event Medical for further instructions on how to address the affected units.
The recalled product
- Product
- Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport.
- Manufacturer
- Event Medical LTD
- Category
- Medical Device — Ventilator
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All models manufactured prior to 2015 are affected
Distribution
Distributed nationwide across the United States.
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