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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CORPORATION LTV; VENTILATOR, CONTINUOUS, FACILITY USE
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CAREFUSION CORPORATION LTV; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 18881-001
Device Problem Ventilation Problem in Device Environment (3027)
Patient Problem Hypoventilation (1916)
Event Date 02/19/2021
Event Type  malfunction  
Event Description
Airway standby while patient is in biplane, patient is on ventilator in at this time, airway intact.Twenty-five minutes later, patient transported from biplane to mri while on ventilator.Eleven minutes later, mri ventilator started to alarm alerting of low minute vent volume.Attempted to trouble shoot ventilator/patient.Unable to trouble shoot after 10-15 seconds.Took patient off ventilator and started to bag the patient will lead respiratory therapist (rt) was being called.Suctioned patient and placed ventilator back on, ventilator still alarming alerting of low min vent.Bagged patient until new mri vent arrived.X-ray was taken.Endotracheal tube (ett) appears to be in good placement.Airway intact.Patient went into mri with new mri ventilator.
 
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Brand Name
LTV
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
CAREFUSION CORPORATION
26125 n. riverwoods blvd.
mettawa IL 60045
MDR Report Key11506027
MDR Text Key240398816
Report Number11506027
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/03/2021,03/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number18881-001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/03/2021
Date Report to Manufacturer03/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age26280 DA
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