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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL BCI ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

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ST PAUL BCI ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number 9004050
Device Problem Calibration Problem (2890)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
It was reported that a smiths medical capnograph is reading zero during patient study. No adverse patient effects were reported.
 
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Brand NameBCI
Type of DeviceANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key12808353
MDR Text Key280771473
Report Number3012307300-2021-11227
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9004050
Device Catalogue Number9004050
Was Device Available for Evaluation? No
Date Returned to Manufacturer11/09/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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