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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 9004000
Device Problem Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/29/2021
Event Type  malfunction  
Manufacturer Narrative
One capnograph was received for evaluation in relation to the reported event. Visual inspection of the device was able to confirm and replicate the reported event. The electric discharge that came out when the ac/dc adapter was plugged into the monitor was duplicated. The root cause of the failure has been determined to be due to the large capacitor on the main board of the power supply with role to accommodate the lack of smoothing caps on the output of the adapter. As a preventive action, the 9004 ifu was updated with the following statement: ?connect the ac charger to the ac power connector of the monitor first and the ac charger to the wall outlet second?. In addition, a warning label was added to the 1616xx power supply's output cable instructing the proper way to connect the power supply in order to eliminate spark. A dhr review was not performed as the issue is not related to a deficiency in the manufacture of the device.
 
Event Description
It was reported that a spark was emitted by this unit while being used by a patient. There was no patient injury 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
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key13483923
MDR Text Key285338798
Report Number3012307300-2022-02938
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 Other Health Care Professional
Type of Report Initial
Report Date 02/08/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number9004000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/26/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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