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U.S. Department of Health and Human Services

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

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ST PAUL BCI CAPNOGRAPHY MONITOR CAPNOCHECK SLEEP ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number 9004050
Device Problem Device Alarm System (1012)
Patient Problem Insufficient Information (4580)
Event Date 10/01/2021
Event Type  malfunction  
Event Description
It was reported that the unit will turn on, then turn off with the alarm led illuminated. The unit will then turn on for a second and show a co2 sensor alarm message. No adverse patient effects were reported.
 
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Brand NameBCI CAPNOGRAPHY MONITOR CAPNOCHECK SLEEP
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
jim vegel
6000 nathan lane north
5808 w 110th st
minneapolis, MN 55442
MDR Report Key12755543
MDR Text Key280464606
Report Number3012307300-2021-10821
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/06/2021
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 Manufacturer10/15/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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