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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Catalog Number C45041345-NLJ
Device Problem Gas/Air Leak (2946)
Patient Problem No Patient Involvement (2645)
Event Date 11/01/2020
Event Type  malfunction  
Manufacturer Narrative
Only the month ((b)(6)) and year (2020) of the event date are known.(b)(6).Device evaluation in progress.
 
Event Description
It was reported that the portex general anesthesia circuit had a leak.This product problem was observed during testing.There was no patient involvement.
 
Manufacturer Narrative
Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source was traced to user interface.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
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Brand Name
PORTEX GENERAL ANESTHESIA CIRCUITS
Type of Device
CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
boundary road
hythe, kent CT21 6JL
UK  CT21 6JL
MDR Report Key11029442
MDR Text Key222269876
Report Number3012307300-2020-12524
Device Sequence Number1
Product Code CAI
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 02/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberC45041345-NLJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2020
Was the Report Sent to FDA? No
Date Manufacturer Received01/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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