BCI CAPNOCHECK II CAPNOGRAPH MONITOR 8400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-11-06 for BCI CAPNOCHECK II CAPNOGRAPH MONITOR 8400 manufactured by Smiths Medical Asd, Inc..

MAUDE Entry Details

Report Number3012307300-2019-05946
MDR Report Key9288466
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-11-06
Date of Report2019-11-06
Date Mfgr Received2019-10-10
Date Added to Maude2019-11-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDAVE HALVERSON
Manufacturer Street6000 NATHAN LANE NORTH
Manufacturer CityMINNEAPOLIS MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer G1SMITHS MEDICAL ASD, INC.
Manufacturer Street6000 NATHAN LANE NORTH
Manufacturer CityMINNEAPOLIS MN 55442
Manufacturer CountryUS
Manufacturer Postal Code55442
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBCI CAPNOCHECK II CAPNOGRAPH MONITOR
Generic NameANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Product CodeCCK
Date Received2019-11-06
Returned To Mfg2019-07-02
Model Number8400
Catalog Number8400
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.