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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL, INC ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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VYAIRE MEDICAL, INC ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Catalog Number AXXXX170
Device Problem Occlusion Within Device (1423)
Patient Problem Extubate (2402)
Event Date 01/29/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4) vyaire has reached out to customer to provide the complaint device for further investigation.At this time we are currently waiting for the sample.If the customer provides the sample for further investigation or additional information is obtained, vyiare will provided a follow up emdr.
 
Event Description
Customer reported "there is no opening in the gas elbow to monitor pco2.The patient required re-intubation with no change in clinical status".
 
Manufacturer Narrative
The vyaire failure analysis lab received the photo of the suspected device/component and performed a visual inspection.The reported issue was confirmed in the laboratory setting.The root cause of the reported issue is: manufacturing equipment failure.
 
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Brand Name
ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG
Type of Device
CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section D)
VYAIRE MEDICAL, INC
26125 n riverwood blvd
mettawa IL 60045
MDR Report Key7270344
MDR Text Key100058743
Report Number8030673-2018-00414
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAXXXX170
Device Lot Number0001189104
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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