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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL BCI CARBON DIOXIDE GAS ANALYZER

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ST PAUL BCI CARBON DIOXIDE GAS ANALYZER Back to Search Results
Model Number 8401
Device Problem Display or Visual Feedback Problem (1184)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
One unit was returned for investigation. Physical investigation found the complained issue to be true. The contrast was adjusted and the image was able to be seen. The lcd screen was found with a missing vertical segment and the co2 pump was found shifted. Due to the damage found, root cause was traced to user impact. Dhr review was not done since the complaint issue was traced to user impact.
 
Event Description
It was reported that the screen was blank.
 
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Brand NameBCI
Type of DeviceCARBON DIOXIDE GAS ANALYZER
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
attn: biomed
minneapolis, MN 55442
MDR Report Key12683038
MDR Text Key278090658
Report Number3012307300-2021-10180
Device Sequence Number1
Product Code CCK
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8401
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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