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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL BCI CARBON DIOXIDE GAS ANALYZER

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ST PAUL BCI CARBON DIOXIDE GAS ANALYZER Back to Search Results
Model Number 9004050
Device Problem Connection Problem (2900)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the luer lock is detaching from the sample line on the rear filter port.
 
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Brand NameBCI
Type of DeviceCARBON DIOXIDE GAS ANALYZER
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key12715215
MDR Text Key279030633
Report Number3012307300-2021-10410
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
PMA/PMN Number
K970209
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 10/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9004050
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/12/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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