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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PORTEX; GENERAL ANESTHESIA CIRCUITS
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PORTEX; GENERAL ANESTHESIA CIRCUITS Back to Search Results
Catalog Number C1038J
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/07/2020
Event Type  malfunction  
Event Description
Information was received that during a pre-use check on the product, an air leak from the anesthesia circuit was detected.Also, the corrugated tube was found torn.No patient injury.
 
Manufacturer Narrative
One breathing circuit device was received for evaluation.Visual inspection of the device found it to have a tear.The device underwent functional testing; the circuit did not pass leak testing.Additionally, a random sample of 32 bags were reviewed during the complete process, the units were visually inspected to verify that all bags were free of damage (tears, scuffs, pinch marks, contamination, etc.), and it was seen that the bags were without damage.No discrepancies were found.The reported customer complaint has been confirmed during testing and the problem source has been determined to be manufacturing.
 
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Brand Name
PORTEX
Type of Device
GENERAL ANESTHESIA CIRCUITS
MDR Report Key10477178
MDR Text Key205123803
Report Number3012307300-2020-08887
Device Sequence Number1
Product Code OFP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 10/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberC1038J
Device Lot Number3930802
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2020
Was the Report Sent to FDA? No
Date Manufacturer Received09/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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