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Event Medical LS, 5I, or 7I Inspiration Ventilators May Shut Down Without Alarm

The FDA issued a Class I recall for certain eVent Medical Inspiration ventilator models due to a faulty switch that could cause the ventilator to shut down without warning. The recall affects 251 units nationwide manufactured before January 2015. One event of shutdown was reported without injury. Users are instructed to immediately discontinue use and contact the company for corrective action instructions.

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133 views3 pages

Event Medical LS, 5I, or 7I Inspiration Ventilators May Shut Down Without Alarm

The FDA issued a Class I recall for certain eVent Medical Inspiration ventilator models due to a faulty switch that could cause the ventilator to shut down without warning. The recall affects 251 units nationwide manufactured before January 2015. One event of shutdown was reported without injury. Users are instructed to immediately discontinue use and contact the company for corrective action instructions.

Uploaded by

Taha Obed
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Medical Device Recalls > eVent Medical LS, 5i, or 7i Inspiration Ventilators May Shut Down without Alarm

 U.S. Food and Drug Search FDA 


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eVent Medical LS, 5i, or 7i Inspiration


Ventilators May Shut Down without Alarm
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The FDA has identified this as a Class I recall, the most serious
type of recall.  Use of
these devices may cause serious injuries or death

Recalled Device

All models of eVent Medical LS, 5i and 7i Inspiration ventilators manufactured prior
to January 21, 2015
Distribution Dates: February 14, 2013 to December 31, 2014
Devices Recalled in the U.S.: 251 Units Nationwide

Device Use
The Inspiration LS, 5i and 7i ventilator systems provide constant breathing support for
infants and adults. The ventilator is used in hospitals or health care facilities.

Inspiration 5i Ventilator

Reason for Recall


eVent Medical is recalling the LS, 5i, or 7i Inspiration ventilators because a faulty

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm475862.htm[12/7/2015 5:07:05 PM]


Medical Device Recalls > eVent Medical LS, 5i, or 7i Inspiration Ventilators May Shut Down without Alarm

switch on the ventilators’ power board may fail, causing the ventilator to shut down
without sounding an alarm.  If the ventilator shuts down, the patient may not receive
enough oxygen and
could suffer serious adverse health consequences, including
injury or death. 

The company has received one report of this issue occurring, with no injuries and no
deaths.

Who may be affected

Health care providers using eVent Inspiration LS, 5i and 7i ventilators


All patient groups who may be using these ventilator systems for breathing support.

What to Do
The firm sent an urgent field safety notice to all customers on October 13, 2015
informing them of this issue. The letter advised customers to immediately discontinue
use of the affected ventilators until corrective actions could be taken. 

To mitigate the risk of ventilator failure, the firm attached the instructions for removing
the potentially faulty component from the power board. 

Contact Information
Customers with questions are instructed to call eVent customer service: (949) 900-
1917

Date Recall Initiated  


October 13, 2015

How do I report a problem?


Health care professionals and consumers may report adverse reactions or quality
problems they experienced using these devices to MedWatch: The FDA Safety
Information and Adverse Event Reporting Program either online, by regular mail or by
FAX

Additional Resources

Class 1 Recall Inspiration Ventilator System

More in Medical Device Recalls

2015 Medical Device Recalls

2014 Medical Device Recalls

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm475862.htm[12/7/2015 5:07:05 PM]


Medical Device Recalls > eVent Medical LS, 5i, or 7i Inspiration Ventilators May Shut Down without Alarm


Page Last Updated: 12/07/2015


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http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm475862.htm[12/7/2015 5:07:05 PM]

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