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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC VELA VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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CAREFUSION, INC VELA VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number VELA
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 10/11/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).In the event the device is received for evaluation or additional information is received a follow-up report will be submitted.At this time, carefusion has not received the suspect device/component from the customer for evaluation.(b)(4).
 
Event Description
It was reported that the ventilator was alarming vent inoperable, motor fault, low peak inspiratory pressure (pip), and low exhaled volume (ve).There was no patient involvement.
 
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Brand Name
VELA VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
CAREFUSION, INC
22745 savi ranch parkway
yorba linda CA 92887
Manufacturer (Section G)
CAREFUSION, INC
1100 bird center dr.
palm springs CA 92262
Manufacturer Contact
jill rittorno
22745 savi ranch parkway
yorba linda, CA 92887
MDR Report Key6216515
MDR Text Key63829586
Report Number2021710-2016-05158
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K093094
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVELA
Device Catalogue Number16532-14
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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