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 2020-03-16 for LEVEL 1 H-1200 FAST FLOW FLUID WARMER 8002950 manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[183478290] Device evaluation: returned device was received in good physical condition. During the evaluation the device was powered on the device and notice no fluid recirculating. Back panel was removed for further investigation. Visually inspection and found that pump making noise, faulty pump. Tested compressor and regulator and passed functional tests. The customer reported condition was confirmed. Problem source was traced to the supplier. The original dhr is no longer applicable as the device was manufactured in 2017. Investigation results do not implicate a service or manufacturing process.
Patient Sequence No: 1, Text Type: N, H10


[183478291] Information was received that a smiths medical level 1 h-1200 fast flow fluid warmer has a compressor and regulator needs to be replaced. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-01877
MDR Report Key9833562
Report SourceUSER FACILITY
Date Received2020-03-16
Date of Report2020-03-15
Date Mfgr Received2020-02-14
Device Manufacturer Date2017-04-24
Date Added to Maude2020-03-16
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 Street1265 GREY FOX ROAD
Manufacturer CityST. PAUL, MN
Manufacturer CountryUS
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 Received2020-03-16
Returned To Mfg2019-11-14
Model Number8002950
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 2020-03-16

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