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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BCI CAPNOCHECK SLEEP OXIMETER; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

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SMITHS MEDICAL ASD, INC. BCI CAPNOCHECK SLEEP OXIMETER; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number 9004050
Device Problems Calibration Problem (2890); Charging Problem (2892)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Device evaluation : one bci monitor and adapter was received for investigation in good condition.After charging the 9004050 monitor overnight, pressing the on/off button to power up the monitor, it was determined the device would not turn on.Next, the investigator plugged in the ac/dc 1616 adapter for a factory calibration.Without using the power from the main battery, and only taking power from the ac/dc 1616 power supply, the monitor would not power on.Therefore, the main board was replaced.The main board failure confirms the customer's reported complaint.In addition, the device co2 and flow rate was tested with flow of 166 ml/min (spec: 150+/-20ml/min) and passed.Furthermore, it was detected that the tamper sticker was not intact, implying customer may have induced damage.The charging circuit on the mainboard failing to charge battery was noted to be known for resulting from the use of wrong power supply, causing the mainboard to short.Based on the evidence, the complaint allegation was confirmed.The failure likely resulted from a user error failing to follow the correction instructions from the operator's manual (chapter one) where it states ""patient safety can be compromised by the use of a power supply not supplied by smiths medical.Use only the power supply included with your monitor, or approved by smiths medical.".
 
Event Description
Information was received that a smiths medical bci capnocheck sleep oximeter had a charging circuit issue.The reporter also stated the device "required factory calibration".No adverse effects were reported.
 
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Brand Name
BCI CAPNOCHECK SLEEP OXIMETER
Type of Device
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key9132077
MDR Text Key162528180
Report Number3012307300-2019-05194
Device Sequence Number1
Product Code CCK
UDI-Device Identifier10610586036866
UDI-Public10610586036866
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K970209
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number9004050
Device Catalogue Number9004050
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2018
Initial Date Manufacturer Received 11/29/2018
Initial Date FDA Received09/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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