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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. CAREFUSION VITAL SIGNS ANESTHESIA BREATHING CIRCUIT; FILTER, BACTERIAL, BREATHING-CIRCUIT
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VYAIRE MEDICAL, INC. CAREFUSION VITAL SIGNS ANESTHESIA BREATHING CIRCUIT; FILTER, BACTERIAL, BREATHING-CIRCUIT Back to Search Results
Catalog Number A5Z11XXX
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Gas/Air Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/22/2019
Event Type  malfunction  
Event Description
Circuits did not pass our anesthesia daily machine tests in room or11.Circuit had a huge leak of 625 and you could see there are tiny microscopic holes in the lines.The vital signs adult anesthesia breathing circuit should pass with 0-100 leak.In or 5 during my daily anesthesia machine test with new circuits.The adult circuit failed with a huge leak of 525.The adult circuit did have small holes for this issue to occur.The vital signs adult breathing circuit should pass with a 0-100 leak.Tech reported this has been happening for a little while.Since they have seen a trend, they have started reporting.We have a total of 3 circuits that have failed.
 
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Brand Name
CAREFUSION VITAL SIGNS ANESTHESIA BREATHING CIRCUIT
Type of Device
FILTER, BACTERIAL, BREATHING-CIRCUIT
Manufacturer (Section D)
VYAIRE MEDICAL, INC.
26125 n. riverwoods blvd
mettawa IL 60045
MDR Report Key9495270
MDR Text Key172011067
Report Number9495270
Device Sequence Number1
Product Code CAH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberA5Z11XXX
Device Lot Number0004076169
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/05/2019
Device Age11 MO
Event Location Hospital
Date Report to Manufacturer12/19/2019
Type of Device Usage N
Patient Sequence Number1
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