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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL INC. LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT; ANESTHESIA CIRCUITS
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VYAIRE MEDICAL INC. LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT; ANESTHESIA CIRCUITS Back to Search Results
Model Number LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2021
Event Type  malfunction  
Manufacturer Narrative
No sample or picture was provided for the investigation.Therefore, could not confirm reported defect.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
 
Event Description
The customer reported that the limb-o¿ single limb anesthesia breathing circuit experienced 750ml circuit leak due to have a cut in the green bag.The customer confirmed that there was no patient harm associated with the reported event.
 
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Brand Name
LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
Type of Device
ANESTHESIA CIRCUITS
Manufacturer (Section D)
VYAIRE MEDICAL INC.
26125 n. riverwoods blvd.
mettawa IL 60045
MDR Report Key12366407
MDR Text Key268102747
Report Number8030673-2021-00188
Device Sequence Number1
Product Code CAI
UDI-Device Identifier10190752121980
UDI-Public(01)10190752121980
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
Report Date 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
Device Catalogue NumberAFNX2004
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received08/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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