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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERSURGICAL UAB 30MM UNIFLOW COAXIAL BREATHING SYSTEM WITH LUER ELBOW AND LIMB 2.4M CIRCUIT, BREATHING SYSTEM

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INTERSURGICAL UAB 30MM UNIFLOW COAXIAL BREATHING SYSTEM WITH LUER ELBOW AND LIMB 2.4M CIRCUIT, BREATHING SYSTEM Back to Search Results
Model Number 2901000
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem Test Result (2695)
Event Date 01/21/2020
Event Type  Injury  
Manufacturer Narrative
The product complaint occured outside us. The problem had been caused by breakage of universal f inner swivel connector, which connects the inner tube to the t-piece at the machine end. No signs of mechanical impact found when visually inspecting returned sample. The same connector is used in many other catalogue numbers. Total quantities sold of all uniflow systems in uk / europe / worldwide during last 12 months are as follows: 50,658 / 581,508 / 751,371 units. No similar reports received for any catalogue number during last 12 months therefore we believe the issue is not widespread. The tests carried out at the manufacture include separate leakage testing of the inner and outer tubes therefore we believe the connector did brake after the system was assembled and packed. The issue had to be identified during the pre use checks when testing the inner tube for leakage. A red inner lumen leak tester with the instruction how to use it is in the bag for this purpose.
 
Event Description
"patient was asleep and the anaesthetist notice the co2 level was not right so on further investigation he found the faulty circuit and changed it in around a couple of minutes. No harm as circuit replaced".
 
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Brand Name30MM UNIFLOW COAXIAL BREATHING SYSTEM WITH LUER ELBOW AND LIMB 2.4M
Type of DeviceCIRCUIT, BREATHING SYSTEM
Manufacturer (Section D)
INTERSURGICAL UAB
arnioniu 60/28-1
pabrade, lh, lithuania
LH
Manufacturer Contact
ivan seniut
arnioniu 60/28-1
pabrade, vilniaus apskritis, LT-47-10
LH   LT-4710
MDR Report Key9973540
MDR Text Key191867226
Report Number1319447-2020-00002
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial
Report Date 04/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2901000
Device Lot Number31960115
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Device Age1 YR
Event Location Hospital
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/17/2020 Patient Sequence Number: 1
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