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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. BCI® CAPNOCHECK® SLEEP CAPNOGRAPH/OXIMETER ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Catalog Number 9004051
Device Problems Overheating of Device (1437); Smoking (1585)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device is currently being evaluated; smiths medical will file a follow-up report detailing the results of the evaluation once it is completed. Device evaluation in progress.
 
Event Description
It was reported that a bci® capnocheck® sleep capnograph/oximeter was hot and smoking. The device's green power light did not function. No patient injury was reported.
 
Manufacturer Narrative
One bci® capnocheck® sleep capnograph/oximeter was returned for investigation. Visual inspection of the device revealed that the tamper sticker had been removed and the battery was disconnected from the mainboard inside the device. Additionally, it was noted that the rechargeable battery was not a designated battery that smiths medical installs. During functional testing, the device was powered on with a test power supply and it was noted that the power/charge green indicator light did not power on. The device was opened and examined and it was observed that the heatsink was warmer than usual; however, no smoke was found escaping from the device. Further examination of the device found that the output voltage at the charging section of the main board was elevated which resulted in excessive voltage being delivered to the heatsink. The excess voltage at the heatsink caused the heatsink to overheat. Additionally, the switch output voltage at the regulator was too low to turn the device on with ac power and the battery was not charging. The observed missing tamper sticker and the non-smiths medical designated battery indicated that the device was tampered with by the user; therefore, investigation was unable to determine the root cause of the failed mainboard component. After device repair and recalibration, the device was found to pass all delivery, accuracy and functional tests.
 
Event Description
It was further reported that there was no patient or staff involvement when the reported issue occurred.
 
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Brand NameBCI® CAPNOCHECK® SLEEP CAPNOGRAPH/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.
3350 granada avenue
oakdale MN 55128
Manufacturer Contact
lisa perz
6000 nathan lane north
minneapolis, MN 55442
7633833074
MDR Report Key6315691
MDR Text Key67223002
Report Number3012307300-2017-00341
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
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number9004051
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/15/2013
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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