LEVEL 1 H-1200 FAST FLOW FLUID WARMER 8002950

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 2020-02-09 for LEVEL 1 H-1200 FAST FLOW FLUID WARMER 8002950 manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[178325610] Information was received that a smiths medical level 1 h-1200 fast flow fluid warmer unit will not turn on. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-00930
MDR Report Key9685075
Report SourceUSER FACILITY
Date Received2020-02-09
Date of Report2020-02-06
Date Mfgr Received2020-01-09
Device Manufacturer Date2016-06-27
Date Added to Maude2020-02-09
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 NORTH
Manufacturer CityMINNEAPOLIS MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer G1SMITHS MEDICAL ASD, INC
Manufacturer Street1265 GREY FOX ROAD
Manufacturer CityST. PAUL MN 55112
Manufacturer CountryUS
Manufacturer Postal Code55112
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEVEL 1 H-1200 FAST FLOW FLUID WARMER
Generic NameWARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION PRODUCT CODE: BSB
Product CodeBSB
Date Received2020-02-09
Returned To Mfg2019-01-14
Model Number8002950
Catalog Number8002950
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-09

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