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U.S. Department of Health and Human Services

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

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ST PAUL CAPNOCHECK II, MODEL 8400 ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number 8400
Device Problem Device Alarm System (1012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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Brand NameCAPNOCHECK 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
minneapolis, MN 55442
MDR Report Key15330207
Report Number3012307300-2022-17110
Device Sequence Number1
Product Code CCK
UDI-Device Identifier10610586036354
UDI-Public10610586036354
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 Operator
Device Model Number8400
Device Catalogue Number8400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2021
Was the Report Sent to FDA? No
Date Manufacturer Received05/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/28/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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