LEVEL 1? HOTLINE? TRAUMA FAST FLOW SYSTEM H-1200 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 2020-02-19 for LEVEL 1? HOTLINE? TRAUMA FAST FLOW SYSTEM H-1200 8002950 manufactured by Smiths Medical Asd; Inc..

Event Text Entries

[180112268] Information was received indicating that a smiths medical level 1? Hotline? Trauma fast flow system was noted to continually alarm warranty box. There were no reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-01335
MDR Report Key9730090
Report SourceUSER FACILITY
Date Received2020-02-19
Date of Report2020-02-19
Date Mfgr Received2020-01-21
Device Manufacturer Date2019-04-25
Date Added to Maude2020-02-19
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 Phone7633833310
Manufacturer G1SMITHS MEDICAL ASD; INC.
Manufacturer Street6000 NATHAN LANE N
Manufacturer CityMINNEAPOLIS, MN 55442
Manufacturer CountryUS
Manufacturer Postal Code55442
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEVEL 1? HOTLINE? TRAUMA FAST FLOW SYSTEM
Generic NameWARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
Product CodeBSB
Date Received2020-02-19
Model NumberH-1200
Catalog Number8002950
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD; INC.
Manufacturer Address6000 NATHAN LANE N MINNEAPOLIS, MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-19

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