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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE IVENT; VENTILATOR
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GE IVENT; VENTILATOR Back to Search Results
Model Number 201
Device Problems Premature Discharge of Battery (1057); Failure to Charge (1085); Device Inoperable (1663); Out-Of-Box Failure (2311); Battery Problem (2885)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Event Description
We purchased 5 news ivents i believe in 2014 and had issues out of the box.One had to be returned out of the box.All others had continual battery issues with no resolution from the company.Have tried multiple extended batteries with no resolution.Vents have gone inop on patients and stopped ventilating, they have said fully charged and then died, some will not charge at all.We are now even having issues with one of our older ones that is about 6 years old.This has become a significant safety issue for our patients.If no resolution we will be forced to take all of them out of service.Ge has moved production of these vents to (b)(4) and stopped sales in the us.As far as i am aware there is little to no support for these vents in the us at this time.I can see an issue with one vent, however this is a fleet of 7 vents that have all had issues.We do currently have one of the older ones still running without the many issues of the newer ones.All five of the newer ones are experiencing these major issues.
 
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Brand Name
IVENT
Type of Device
VENTILATOR
Manufacturer (Section D)
GE
MDR Report Key5690722
MDR Text Key46494456
Report NumberMW5062550
Device Sequence Number1
Product Code CBK
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/25/2016
8 Devices were Involved in the Event: 1   2   3   4   5   6   7   8  
1 Patient was Involved in the Event
Date FDA Received05/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number201
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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