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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PORTEX® ADULT DISPOSABLE ANESTHESIA BREATHING CIRCUITS; CIRCULATOR, BREATHING-CIRCUIT
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PORTEX® ADULT DISPOSABLE ANESTHESIA BREATHING CIRCUITS; CIRCULATOR, BREATHING-CIRCUIT Back to Search Results
Catalog Number C49291349-NLJ
Device Problems Device Alarm System (1012); Leak/Splash (1354); Gas/Air Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/01/2020
Event Type  malfunction  
Event Description
Information was received indicating that an air leak alarm occurred to a smiths medical portex® adult disposable anesthesia breathing circuit during pre-use check.The alarm stopped after changing the product out with another one.There were no reported adverse effects.
 
Manufacturer Narrative
One general anesthesia circuit was returned for analysis in used condition.No discrepancies were noted upon visual inspection.Functional testing was performed by using a gauge; not passing leak testing.An audit of leak testing and visual inspection was performed on 32 units from the manufacturing process; no discrepancies found.Based on the evidence, it as unknown as to the cause of the complaint as the complaint was not confirmed.
 
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Brand Name
PORTEX® ADULT DISPOSABLE ANESTHESIA BREATHING CIRCUITS
Type of Device
CIRCULATOR, BREATHING-CIRCUIT
MDR Report Key9966031
MDR Text Key187864063
Report Number3012307300-2020-02985
Device Sequence Number1
Product Code CAG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberC49291349-NLJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2020
Date Manufacturer Received04/26/2020
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 Unknown
Patient Sequence Number1
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