• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITHS MEDICAL ASD, INC. BCI CAPNOCHECK SLEEP CAPNOGRAPH MONITOR ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE Back to Search Results
Model Number 9004050
Device Problems Sparking (2595); Calibration Problem (2890)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Information was received that a smiths medical bci capnocheck sleep capnograph monitor sparked when the device was plugged in. It was also noted that the monitor could not calibrate. No adverse effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBCI CAPNOCHECK SLEEP CAPNOGRAPH MONITOR
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 Key8911773
MDR Text Key154924574
Report Number3012307300-2019-04257
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 user facility
Reporter Occupation
Type of Report Initial
Report Date 08/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9004050
Device Catalogue Number9004050
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/07/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-