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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL LEVEL 1 HOTLINE LOW FLOW SYSTEM (HL-90); WARMER, THERMAL, INFUSION FLUID
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ST PAUL LEVEL 1 HOTLINE LOW FLOW SYSTEM (HL-90); WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-90
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problems No Patient Involvement (2645); No Information (3190)
Event Date 10/01/2020
Event Type  malfunction  
Manufacturer Narrative
Device evaluation in progress.
 
Event Description
It was reported that the level 1 hotline low flow system (hl-90) was tripping the line isolation in the or room.No patient injury or complications were reported in relation to this event.
 
Manufacturer Narrative
Other, other text: additional information- "no patient involvement" added to section b5.Device evaluation- the device was returned for evaluation.The device was found operating as expected.However when tested for electrical safety a surge in current was detected.The cause of the issue not definitely established.
 
Event Description
No patient involvement.
 
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Brand Name
LEVEL 1 HOTLINE LOW FLOW SYSTEM (HL-90)
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key10645575
MDR Text Key210363498
Report Number3012307300-2020-10227
Device Sequence Number1
Product Code LGZ
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
Report Date 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHL-90
Device Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2020
Was the Report Sent to FDA? No
Date Manufacturer Received10/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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