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U.S. Department of Health and Human Services

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

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ST PAUL BCI CAPNOGRAPHY MONITOR CAPNOCHECK CARBON DIOXIDE GAS ANALYZER Back to Search Results
Model Number 9004050
Device Problem Key or Button Unresponsive/not Working (4063)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2021
Event Type  malfunction  
Event Description
It was reported that the front panel down arrow is not working on a smiths medical capnograph. No patient involvement.
 
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Brand NameBCI CAPNOGRAPHY MONITOR CAPNOCHECK
Type of DeviceCARBON DIOXIDE GAS ANALYZER
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
jim vegel
6000 nathan lane north
clincal engineering dept
minneapolis, MN 55442
MDR Report Key12822189
MDR Text Key280878970
Report Number3012307300-2021-11169
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K970209
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/05/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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