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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL WARMER; LEVEL ONE
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ST PAUL WARMER; LEVEL ONE Back to Search Results
Model Number 115
Device Problems Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198)
Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the display on the level 1 hotline low flow system (hl-90) had malfunctioned.No patient injury or complications were reported in relation to this event.
 
Manufacturer Narrative
Other, other text: investigation completed on a smiths medical fluid warming|level 1 hotline low flow systems - hl-90 complaint of display malfunctioning was confirmed when filling the water talk and powering on.The physical condition of device was good.Lcd only displays 1.The cause was isolated to pcb board with contain lcd.Action was taken to replace the primary circuit board.Device then passed all testing.
 
Event Description
Information received a smiths medical fluid warming|level 1 hotline low flow systems - hl-90 display is malfunctioning.No patient involvement during event.
 
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Brand Name
WARMER
Type of Device
LEVEL ONE
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11365048
MDR Text Key233043182
Report Number3012307300-2021-01460
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 04/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number115
Device Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2021
Was the Report Sent to FDA? No
Date Manufacturer Received03/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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