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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 Problem No Information (3190)
Event Type  malfunction  
Event Description
It was reported that the led lights were not working on the level 1 hotline low flow system (hl-90).No patient injury, or complications were reported in relation to this event.
 
Manufacturer Narrative
Other, other text: returned device was received leds on pcb were broken off, enclosure was stained red in water tank, both covers were cracked, heater did not pass electrical testing and line cord was worn.During the evaluation of the device the customer reported condition was confirmed.Problem source was traced to user interface.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
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 Key10649728
MDR Text Key210429458
Report Number3012307300-2020-10240
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 11/29/2020
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 Health Professional
Device Model NumberHL-90
Device Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/08/2020
Initial Date FDA Received10/08/2020
Supplement Dates Manufacturer Received10/29/2020
Supplement Dates FDA Received11/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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