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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL BCI CAPNOCHECK II, MODEL 8400 ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

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ST PAUL BCI CAPNOCHECK II, MODEL 8400 ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number 8401
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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Brand NameBCI CAPNOCHECK II, MODEL 8400
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
7101 s padre island dr
minneapolis, MN 55442
MDR Report Key15329036
Report Number3012307300-2022-17079
Device Sequence Number1
Product Code CCK
UDI-Device Identifier10610586036781
UDI-Public10610586036781
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K991086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation
Type of Report Initial
Report Date 08/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number8401
Device Catalogue Number8401
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2020
Was the Report Sent to FDA? No
Date Manufacturer Received05/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/08/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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