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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PORTEX; BREATHING CIRCUITS
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PORTEX; BREATHING CIRCUITS Back to Search Results
Catalog Number C1038J
Device Problem Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2021
Event Type  malfunction  
Event Description
Information received a smiths medical breathing|portex general anesthesia circuits malfunctioned.During a pre-use check, leakage of air from the product was observed.The customer further evaluated it and found a crack in the breathing circuit.Also, air was leaking from the crack.No patient injury occurred.
 
Manufacturer Narrative
Other text: investigation completed on a smiths medical breathing|portex general anesthesia circuits.One unit returned and failure and pictures provided.Leakage testing done with equipment and this revealed circuit has a crack.The device passes all functional testing prior to release.Cannot be confirmed the failure, the most probable root cause is that crack occurred after the product left smiths medical facilities.
 
Event Description
Investigation completed and summary in h 10.
 
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Brand Name
PORTEX
Type of Device
BREATHING CIRCUITS
MDR Report Key11852505
MDR Text Key251653438
Report Number3012307300-2021-04672
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 08/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberC1038J
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2021
Was the Report Sent to FDA? No
Date Manufacturer Received07/25/2021
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 Sequence Number1
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