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U.S. Department of Health and Human Services

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

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ST PAUL BCI ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number 9004051
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Insufficient Information (4580)
Event Date 10/13/2021
Event Type  malfunction  
Event Description
It was reported that the comport and signals are incorrect on a smiths medical capnograph. No adverse patient effects were reported.
 
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Brand NameBCI
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
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key12808294
MDR Text Key280770280
Report Number3012307300-2021-11202
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
Reporter Occupation
Type of Report Initial
Report Date 11/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9004051
Device Catalogue Number9004051
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2021
Was the Report Sent to FDA? No
Date Manufacturer Received10/26/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/11/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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