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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 3100A HFOV; VENTILATOR, HIGH FREQUENCY
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CAREFUSION 3100A HFOV; VENTILATOR, HIGH FREQUENCY Back to Search Results
Model Number 3100A
Device Problems Calibration Problem (2890); Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/11/2016
Event Type  malfunction  
Event Description
Patient repositioned.The ventilator was alarming low pressure.Attempts made to adjust control to correct alarm condition.Visually inspected the circuit/vent for disconnection, there was none.The ventilator would not pressurize.Patient was removed and new ventilator put in place.No patient harm.Manufacturer response for ventilator, 3100a oscillator (per site reporter): our tech performed circuit calibration and ventilation performance check.Both were slightly substandard.Circuit replaced.Vent then met manufacturers specs.Manufacturers' service technician was to be onsite approximately a week ago to inspect the device.
 
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Brand Name
3100A HFOV
Type of Device
VENTILATOR, HIGH FREQUENCY
Manufacturer (Section D)
CAREFUSION
22745 savi ranch parkway
yorba linda CA 92887
MDR Report Key5748056
MDR Text Key48118089
Report Number5748056
Device Sequence Number1
Product Code LSZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number3100A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/26/2016
Event Location Hospital
Date Report to Manufacturer05/26/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/24/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Weight1
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