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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL LEVEL 1 HOTLINE LOW FLOW SYSTEMS; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
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SMITHS MEDICAL ASD, INC. SMITHS MEDICAL LEVEL 1 HOTLINE LOW FLOW SYSTEMS; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION Back to Search Results
Catalog Number CON-HL-390
Device Problem Device Alarm System (1012)
Patient Problems No Patient Involvement (2645); No Information (3190)
Event Type  malfunction  
Event Description
Information was received that a smiths medical level 1 hotline low flow system has a constant low water alarm.No adverse effects reported.
 
Manufacturer Narrative
Additional information received indicating that there was no paitent involvement and that the fault occurred during pre-test.
 
Manufacturer Narrative
Evaluation results: one level 1 trauma fast flow system (hl-390) was returned for investigation in good condition.Visual inspection revealed that the enclosure was dirty and scuffed.The water tank cover was leaking water, and a constant low water alarm was observed when the device was powered on.  the line cord was also worn, and the main block was leaking water.The investigator subsequently filled the tank with water and plugged in the line cord, and turned on the power switch.The customer reported product problem (constant low water alarm) was confirmed during testing.The product problem was attributed to a bad float switch.The following components were replaced: enclosure, front cover and water tank cover.The investigator also installed a newer gasket on the water tank cover and replaced the drain fitting and line cord.The main block was replaced as well.Preventative maintenance was then performed.The device subsequently passed functional testing.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
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Brand Name
SMITHS MEDICAL LEVEL 1 HOTLINE LOW FLOW SYSTEMS
Type of Device
WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane n
minneapolis MN 55442
MDR Report Key9418739
MDR Text Key169308874
Report Number3012307300-2019-07013
Device Sequence Number1
Product Code BSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup,Followup
Report Date 04/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberCON-HL-390
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2020
Date Manufacturer Received03/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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