LEVEL 1 TRAUMA FAST FLOW SYSTEM H1200 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 2020-03-03 for LEVEL 1 TRAUMA FAST FLOW SYSTEM H1200 8002950 manufactured by Smiths Medical Asd, Inc.

Event Text Entries

[181924411] Evaluation results: one level 1 trauma fast flow system with a h-2 pressure cuff was received in fair condition. The device was manufactured in 2007. Visual inspection revealed that the h-31b air detector optical key sensor assembly was broken due to customer damage. The customer reported product problem was therefore confirmed. The h-31 optical key sensor assembly and mount block assembly were replaced as a result. A tempcheck test fixture was fitted on the device. The measured temperature was 41. 7 degrees which was within tolerance. The unit passed all functional and electrical tests.
Patient Sequence No: 1, Text Type: N, H10


[181924412] It was reported that the air detector key sensor was broken. The product problem was observed during preventative maintenance. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-01636
MDR Report Key9782476
Report SourceUSER FACILITY
Date Received2020-03-03
Date of Report2020-03-03
Date Mfgr Received2019-07-18
Device Manufacturer Date2007-05-31
Date Added to Maude2020-03-03
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 Received2020-03-03
Returned To Mfg2019-07-30
Model NumberH1200
Catalog Number8002950
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS, MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-03

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