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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD; INC. BCI CAPNOCHECK II CAPNOGRAPH ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number 8400
Device Problems Crack (1135); Battery Problem (2885); Power Problem (3010)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
One capnography monitor was returned for analysis in bad condition. Upon visual inspection it was found that the battery compartment was cracked open. A battery was inserted, and unit did not power up. The battery compartment was observed to have been glued back together several times. The top of the pump was found that it had come off completely upon internal visual inspection. The main board was replaced, and the unit then powered up. However, the left side of the display was missing. Based on the evidence, the complaint was confirmed. The root cause was found to be user interface as the unit appeared to be severely damaged from a drop.
 
Event Description
Information was received indicating that a smiths medical bci® capnocheck® ii capnograph would not turn on. New batteries were placed with still no power. It was reported that this fault did not occur during patient use. There were no reported adverse effects.
 
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Brand NameBCI CAPNOCHECK II CAPNOGRAPH
Type of DeviceANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, MN 55442
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis,, MN 55442
7633833310
MDR Report Key9521891
MDR Text Key177563370
Report Number3012307300-2019-07466
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 12/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8400
Device Catalogue Number8401
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2019
Was Device Evaluated by Manufacturer? Yes
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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