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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL GENERAL ANESTHESIA CIRCUITS; BREATHING
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ST PAUL GENERAL ANESTHESIA CIRCUITS; BREATHING Back to Search Results
Catalog Number C37101307J
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2020
Event Type  malfunction  
Event Description
Information received on a smiths medical breathing|portex general anesthesia circuits were leaking when set up.No patient adverse event occurred.
 
Manufacturer Narrative
Other, other text: investigation completed on a smiths medical breathing|portex general anesthesia circuits complaint of leaking was not confirmed in pictures sent, as no product was returned.Sample from p/n c37101307j, l/n 3973608 were tested and failure mode was not confirmed.Device manufacturing was reviewed and no discrepancies prior to release in engineering.There was a capa 000415 opened on 22/dec/2017, in order to determine the root cause and implement proper corrective actions for leaking.By the time this report has been completed capa 000415 was closed on november 2020 corrective actions are addressed on capa 000415.
 
Event Description
Investigation completed on a smiths medical breathing|portex general anesthesia circuits summary in h 10.
 
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Brand Name
GENERAL ANESTHESIA CIRCUITS
Type of Device
BREATHING
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key10865164
MDR Text Key217079106
Report Number3012307300-2020-11570
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 01/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date05/03/2023
Device Catalogue NumberC37101307J
Device Lot Number3973608
Was Device Available for Evaluation? No
Date Returned to Manufacturer10/23/2020
Was the Report Sent to FDA? No
Date Manufacturer Received12/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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