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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL NEO-VERSO Y NEONATAL/INFANT AIRWAY ACCESS ADAPTER CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

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VYAIRE MEDICAL NEO-VERSO Y NEONATAL/INFANT AIRWAY ACCESS ADAPTER CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Model Number CSC300
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 10/06/2021
Event Type  malfunction  
Event Description
Nurse was repositioning patient and adjusted airlife neo-verso y adapter on endotracheal tube and a piece of plastic broke off into her hand. Entire adapter needed to be changed.
 
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Brand NameNEO-VERSO Y NEONATAL/INFANT AIRWAY ACCESS ADAPTER
Type of DeviceCIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd
mettawa IL 60045
MDR Report Key12689610
MDR Text Key278162489
Report Number12689610
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 10/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCSC300
Device Catalogue NumberCSC300
Device Lot Number2007020001
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/14/2021
Event Location Hospital
Date Report to Manufacturer10/25/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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