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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL LEVEL 1; WARMER, THERMAL, INFUSION FLUID
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ST PAUL LEVEL 1; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Device Problem Defective Component (2292)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Other, other text: one level 1 hotline low flow systems - hl-390 was returned in good condition but had a defective float switch.The investigation started with a visual inspection then the tank was filled with water, attached temp check, plugged in line cord, and turned on power switch.The reported issue was confirmed.The faulty float switch was not triggering an alarm when it should.The switch was replaced to resolve the issue.
 
Event Description
Information was received indicating that the level 1 hotline low flow systems - hl-390 had a defective float switch.There were no adverse events reported.
 
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Brand Name
LEVEL 1
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key10064200
MDR Text Key191238584
Report Number3012307300-2020-04488
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/18/2020
Initial Date FDA Received05/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/20/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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