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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

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VYAIRE MEDICAL LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Model Number LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
Device Problem Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). At this time, the suspect device has not been returned for evaluation. Therefore, the root cause has not been determined yet vyaire medical will submit a supplemental report in accordance with 21 cfr section 803. 56 if additional information becomes available.
 
Event Description
It was reported to vyaire medical that the anesthesia machine gave a "check sample line" alarm, and the anesthesia provider could not proceed with the case until the issue was fixed. While troubleshooting the issue, it was discovered that the limb-o¿ single limb anesthesia breathing circuit had a knot in the gas sample line on the inside of the sample. Once the sample was replaced with a new product, the issue was fixed. No patient harm, but there was delay in patient care due to the circuit issue.
 
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Brand NameLIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
Type of DeviceCIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa IL 60045
MDR Report Key11324185
MDR Text Key232169033
Report Number8030673-2021-00151
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 health professional,user faci
Type of Report Initial,Followup
Report Date 01/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
Device Catalogue NumberAGN5241C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2021
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 Treatment Data
Date Received: 02/12/2021 Patient Sequence Number: 1
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