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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID
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ST PAUL LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-390
Device Problem Failure to Calibrate (2440)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/11/2021
Event Type  malfunction  
Manufacturer Narrative
One device was returned for investigation.The returned sample was visually inspected, and the device was noted to have a cracked tank cover and damaged lcd.Small parts of the lcd fell out when the cover was removed.The customer's complaint was confirmed; numbers were bouncing on the screen when plugged in and attempted temperature check.It was determined that the device lcd was not functioning properly due to physical damage, caused by the customer.The device printed circuit board and tank cover were replaced.The manufacturing dhr review was performed and no causes or potential causes to the customer's reported problem were found during the dhr review.
 
Event Description
It was reported that the device would not calibrate, and numbers were bouncing on the screen.No patient was involved.
 
Manufacturer Narrative
One device was returned for investigation.The returned sample was visually inspected, and the device was noted to have a cracked tank cover and damaged lcd.Small parts of the lcd fell out when the cover was removed.The customer's complaint was confirmed; numbers were bouncing on the screen when plugged in and attempted temperature check.It was determined that the device lcd was not functioning properly due to physical damage, caused by the customer.The device printed circuit board and tank cover were replaced.The manufacturing dhr review was performed and no causes or potential causes to the customer's reported problem were found during the dhr review.
 
Event Description
It was reported that the device would not calibrate, and numbers were bouncing on the screen.No patient was involved.
 
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Brand Name
LEVEL 1 HOTLINE FLUID WARMER, 390
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
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key13599775
MDR Text Key286154423
Report Number3012307300-2022-04150
Device Sequence Number1
Product Code LGZ
UDI-Device Identifier10695085002796
UDI-Public10695085002796
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K911383
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 02/25/2022
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-390
Device Catalogue NumberHL-390
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/12/2021
Initial Date FDA Received02/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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