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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BCI CAPNOCHECK II CAPNOGRAPH/DIGITAL OXIMETER ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

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SMITHS MEDICAL ASD, INC. BCI CAPNOCHECK II CAPNOGRAPH/DIGITAL OXIMETER ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number 8400D
Device Problems Material Fragmentation (1261); Failure to Calibrate (2440)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Evaluation summary: one bci monitor was received for investigation with a purple boot in good condition. The device history record review was completed. Upon functional testing, it was found that the customer had dropped the monitor and broke the elbow off the valve assembly, confirming the customer's reported problem. The broken co2 valve is consistent with unit being severely impacted from a drop. The protective boot around the housing acts as shock absorber preventing damage to the housing. However, centrifugal forces in the time of impact affects internal components, which usually results in component damage. Based on the investigation evidence, the root cause was determined to be user interface.
 
Event Description
Information was received that a smiths medical bci capnocheck ii capnograph/digital oximeter "will not calibrate" and had "broken pieces inside". No adverse effects were reported.
 
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Brand NameBCI CAPNOCHECK II CAPNOGRAPH/DIGITAL OXIMETER
Type of DeviceANALYZER, 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 Key8294001
MDR Text Key134640943
Report Number3012307300-2019-00480
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
Type of Report Initial
Report Date 01/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8400D
Device Catalogue Number8400D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/12/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/26/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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