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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS PEDIATRIC ANESTHESIA BREATHING CIRCUIT
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VYAIRE MEDICAL VITAL SIGNS PEDIATRIC ANESTHESIA BREATHING CIRCUIT Back to Search Results
Catalog Number B171XXXX
Device Problem No Flow (2991)
Patient Problem Hypoxia (1918)
Event Date 12/18/2018
Event Type  malfunction  
Manufacturer Narrative
Currently, the suspect component is not available for return.Therefore, no further evaluation can be completed at this time.
 
Event Description
Customer reported: tubing easily falls of when expanded: resulting in a circuit disconnect.
 
Manufacturer Narrative
Results of investigation: one sample was received by vyaire's investigation quality team for evaluation.According to the investigation, no issues were found with the sample and components received.Therefore, the defect could not be confirmed.A gauge test was performed to the component and it was found to be acceptable.A cuff inspection was also performed to the tubes and both were found acceptable.It is possible that the disconnection reported by the customer was provoked by an excessive pull force applied to the tube during its handling.
 
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Brand Name
VITAL SIGNS PEDIATRIC ANESTHESIA BREATHING CIRCUIT
Type of Device
ANESTHESIA BREATHING CIRCUIT
Manufacturer (Section D)
VYAIRE MEDICAL
22745 savi ranch pkwy
yorba linda CA 92887
MDR Report Key8248411
MDR Text Key133088970
Report Number8030673-2019-00023
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 12/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberB171XXXX
Device Lot Number0004056693
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2019
Date Manufacturer Received01/14/2019
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
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