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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS PEDIATRIC ANESTHESIA BREATHING CIRCUIT; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE
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VYAIRE MEDICAL VITAL SIGNS PEDIATRIC ANESTHESIA BREATHING CIRCUIT; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE Back to Search Results
Model Number VITAL SIGNS® PEDIATRIC ANESTHESIA BREATHING CIRCUIT
Device Problem Disconnection (1171)
Patient Problem No Information (3190)
Event Date 09/23/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Any additional information received from the customer will be included in a follow-up report.At this time, vyaire has not received the suspect device/component for evaluation.
 
Event Description
The customer reported that the pediatric anesthesia breathing circuit was disconnected at the y connection.At this time, there was no information provided regarding patient involvement in this event.
 
Manufacturer Narrative
Result of investigation: vyaire has not received the suspect device for evaluation, but vyaire failure analysis laboratory performed analysis on device history record, and no issues were found.Due to no sample or picture was provided for evaluation, a complete investigation of the defect reported by the customer could not be performed and a root cause could not be determined.
 
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Brand Name
VITAL SIGNS PEDIATRIC ANESTHESIA BREATHING CIRCUIT
Type of Device
ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE
Manufacturer (Section D)
VYAIRE MEDICAL
22745 savi ranch pkwy
yorba linda CA 92887
MDR Report Key9390487
MDR Text Key196090024
Report Number8030673-2019-00054
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 distributor
Type of Report Initial,Followup
Report Date 11/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVITAL SIGNS® PEDIATRIC ANESTHESIA BREATHING CIRCUIT
Device Catalogue NumberB1754XXX
Device Lot Number0004055484
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/23/2019
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
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