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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CSC500 AIRLIFE¿ VERSO¿ T AIRWAY ACCESS ADAPTER; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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CSC500 AIRLIFE¿ VERSO¿ T AIRWAY ACCESS ADAPTER; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Model Number CSC500 AIRLIFE¿ VERSO¿ T AIRWAY ACCESS ADAPTER
Device Problem Disconnection (1171)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/12/2021
Event Type  malfunction  
Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.If additional information becomes available.
 
Event Description
The customer reported disconnection problem with the airlife¿ verso¿ t airway access adapter y-connector when the patients are in the ventral position.It was stated it is due to the system being much more rigid, and it also signals the presence of water, forcing the disconnection to remove it.No information regarding intervention or injury.
 
Manufacturer Narrative
Result of investigation: the suspect samples are not compatible with patients in a prone position.Therefore, the product was not used in accordance with the instructions for use (ifu).However, suspect sample, picture, or lot number is still not provided.Without any material for investigation, no definitive root cause could be determined.
 
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Brand Name
CSC500 AIRLIFE¿ VERSO¿ T AIRWAY ACCESS ADAPTER
Type of Device
CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
MDR Report Key11449078
MDR Text Key245349356
Report Number3006897516-2021-00001
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 02/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCSC500 AIRLIFE¿ VERSO¿ T AIRWAY ACCESS ADAPTER
Device Catalogue NumberCSC500
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/03/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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