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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION LIMBO-O SINGLE LIMB ANESTHESIA CIRCUIT

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CAREFUSION LIMBO-O SINGLE LIMB ANESTHESIA CIRCUIT Back to Search Results
Catalog Number AGNX204X
Device Problems Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/17/2016
Event Type  malfunction  
Event Description
Anesthesiologist had intubated the patient but was having difficulty ventilating the patient. Switched to ambu bag and ventilated without difficulty. Switched out the anesthesia breathing circuit and ventilation ensued with ease. Initial breathing circuit inspected and found to have a clear plastic covering over the intake valve of the filter.
 
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Brand NameLIMBO-O SINGLE LIMB ANESTHESIA CIRCUIT
Type of DeviceANESTHESIA CIRCUIT
Manufacturer (Section D)
CAREFUSION
22745 savi ranch parkway
yorba linda CA 92887
MDR Report Key5719753
MDR Text Key47203395
Report Number5719753
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/27/2016,06/03/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2016
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAGNX204X
Device Lot Number0000872490
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/27/2016
Event Location Hospital
Date Report to Manufacturer05/27/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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