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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL BCI MULTIPARAMETER MONITOR BCI ADVISOR - 9200 ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

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ST PAUL BCI MULTIPARAMETER MONITOR BCI ADVISOR - 9200 ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number 920654230A
Device Problem Device Alarm System (1012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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Brand NameBCI MULTIPARAMETER MONITOR BCI ADVISOR - 9200
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 Key15328942
Report Number3012307300-2022-17076
Device Sequence Number1
Product Code CCK
UDI-Device Identifier10610586037344
UDI-Public10610586037344
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K030407
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 Number920654230A
Device Catalogue Number920654230A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2020
Was the Report Sent to FDA? No
Date Manufacturer Received04/15/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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