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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 Problems No Audible Alarm (1019); Display or Visual Feedback Problem (1184)
Patient Problems No Patient Involvement (2645); No Information (3190)
Event Type  malfunction  
Event Description
It was reported that the pump on the level 1 hotline low flow system (hl-90) had a faulty display.No patient injury or complications were reported in relation to this event.
 
Manufacturer Narrative
Other, other text: returned device was received in poor physical condition.There was wear and tear on the enclosure, drain fitting, front cover, water tank cover and line cord.During the evaluation of the device, the reported issue was able to be confirmed by analysts.The pcb was found to be damaged.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.
 
Event Description
Additional information received 23 december 2020: issue discovered during testing.No alarm.No patient involvement.
 
Manufacturer Narrative
Other text: additional information updated in h 6.
 
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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 Key11008515
MDR Text Key221460796
Report Number3012307300-2020-12383
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,Followup
Report Date 02/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
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 Manufacturer01/15/2021
Was the Report Sent to FDA? No
Date Manufacturer Received01/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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