SMITHS MEDICAL BCI CAPNOGRAPHY MONITOR CAPNOCHECK II - 8400 8401

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-11-25 for SMITHS MEDICAL BCI CAPNOGRAPHY MONITOR CAPNOCHECK II - 8400 8401 manufactured by Smiths Medical Asd, Inc..

MAUDE Entry Details

Report Number3012307300-2019-06791
MDR Report Key9371231
Report SourceUSER FACILITY
Date Received2019-11-25
Date of Report2019-11-25
Date Mfgr Received2019-11-09
Device Manufacturer Date2012-01-11
Date Added to Maude2019-11-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDAVE HALVERSON
Manufacturer Street6000 NATHAN LANE N
Manufacturer CityMINNEAPOLIS MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer G1SMITHS MEDICAL ASD, INC.
Manufacturer Street3350 GRANADA AVENUE NORTH SUITE 100
Manufacturer CityOAKDALE MN 55128
Manufacturer CountryUS
Manufacturer Postal Code55128
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSMITHS MEDICAL BCI CAPNOGRAPHY MONITOR CAPNOCHECK II - 8400
Generic NameANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Product CodeCCK
Date Received2019-11-25
Returned To Mfg2019-08-06
Catalog Number8401
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address6000 NATHAN LANE N MINNEAPOLIS MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-25

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