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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE NEO-VERSO¿ [?]Y' AIRWAY ACCESS ADAPTER FOR ENDOTRACHEAL TUBES CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

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VYAIRE MEDICAL AIRLIFE NEO-VERSO¿ [?]Y' AIRWAY ACCESS ADAPTER FOR ENDOTRACHEAL TUBES CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Model Number AIRLIFE NEO-VERSO¿ [?]Y' AIRWAY ACCESS ADAPTER FOR ENDOTRACHEAL TUBES
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/06/2021
Event Type  Injury  
Event Description
The customer reported that the nurse was repositioning the patient and adjusted the airlife neo-verso y adapter on endotracheal tube and a piece of plastic broke off into her hand.
 
Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation. No root cause has been determined yet. Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803. 56 if additional information becomes available.
 
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Brand NameAIRLIFE NEO-VERSO¿ [?]Y' AIRWAY ACCESS ADAPTER FOR ENDOTRACHEAL TUBES
Type of DeviceCIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section D)
VYAIRE MEDICAL
510 technology dr
irvine IL 92618
Manufacturer (Section G)
VYAIRE MEDICAL
510 technology dr
irvine IL 92618
Manufacturer Contact
erika bonilla
510 technology dr
irvine, IL 92618
7149227837
MDR Report Key12973067
MDR Text Key285705352
Report Number3006897516-2021-00003
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAIRLIFE NEO-VERSO¿ [?]Y' AIRWAY ACCESS ADAPTER FOR ENDOTRACHEAL TUBES
Device Catalogue NumberCSC300
Device Lot Number2007020001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/12/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/09/2021 Patient Sequence Number: 1
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