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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE/ VERSAMED IVENT VERSAMED VENTILATOR; VENTILATOR, CONTINUOUS FACILITY USE
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GE/ VERSAMED IVENT VERSAMED VENTILATOR; VENTILATOR, CONTINUOUS FACILITY USE Back to Search Results
Model Number IVENT 201
Device Problems Improper Device Output (2953); Ventilation Problem in Device Environment (3027)
Patient Problem Death (1802)
Event Date 03/12/2018
Event Type  Death  
Event Description
Patient was intubated in the icu and placed on a ventilator for transport to mri.In mri ventilator screen began flashing and tv readings were irregular.Staff plugged the ventilator into 3 different outlets without resolution of the issue.Ventilator failed and ambu bag was not immediately available.Code called to obtain additional assistance.Ambu bag was in room 30-45 seconds after ventilator failure.At that time patient continued to have hr and bp.Manual ventilation was difficult due to high resistance.The patient's bp decreased and she went into a pea rhythm.Acls protocols were used without success and the patient expired.Ge was able to obtain logs and is in the process of analyzing the data.We do not at this time believe that the patient's expiration was a result of the ventilator failure but due to the proximity of the two events we believed it to be prudent to report.
 
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Brand Name
IVENT VERSAMED VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS FACILITY USE
Manufacturer (Section D)
GE/ VERSAMED
MDR Report Key7376783
MDR Text Key103792743
Report NumberMW5076166
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
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 03/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIVENT 201
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age66 YR
Patient Weight41
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