LEVEL 1 TRAUMA FAST FLOW SYSTEM H-1000 H-1000-UK-230

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-03-10 for LEVEL 1 TRAUMA FAST FLOW SYSTEM H-1000 H-1000-UK-230 manufactured by Smiths Medical Asd, Inc.

Event Text Entries

[182806744] It was reported that the unit was alarming differently, and not heating beyond 26 degrees celsius. The over-temp alarm was observed during training. No patient injury or complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-01991
MDR Report Key9813909
Report SourceFOREIGN,OTHER,USER FACILITY
Date Received2020-03-10
Date of Report2020-03-10
Date of Event2020-02-12
Date Mfgr Received2020-02-13
Device Manufacturer Date2019-08-15
Date Added to Maude2020-03-10
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
Manufacturer CountryUS
Manufacturer G1SMITHS MEDICAL ASD, INC
Manufacturer Street3350 GRANADA AVENUE NORTH SUITE 100
Manufacturer CityOAKDALE, MN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEVEL 1 TRAUMA FAST FLOW SYSTEM
Generic NameWARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
Product CodeBSB
Date Received2020-03-10
Model NumberH-1000
Catalog NumberH-1000-UK-230
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS, MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-10

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