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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL LEVEL 1 HOTLINE FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

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ST PAUL LEVEL 1 HOTLINE FLUID WARMER; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-90
Device Problem No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2023
Event Type  malfunction  
Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Event Description
It was reported that after an over temp test, the warmer the display went dead.Additional information received on mar 23, 2023 via email: the event occurred in biomed office, the event happened on (b)(6) 2023 and the medical intervention was no.
 
Manufacturer Narrative
One device was received and looked to be in very good condition.No physical damage was noted.Put water in the tank, attached temperature check, plugged line cord into outlet, turned device on.Could not duplicate the reported issue as the liquid crystal display (lcd) would not stabilize and kept fluctuating.The root cause was due to a faulty liquid crystal display (lcd) and/or printed circuit board (pcb).A device history record (dhr) review indicated the liquid crystal display (lcd) and printed circuit board (pcb) operated as intended and displayed accurate temperature reading during assembly and all functional tests passed.Replaced printed circuit board (pcb).Performed preventative maintenance (pm) and calibrated the device.All functional tests passed.
 
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Brand Name
LEVEL 1 HOTLINE FLUID WARMER
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
Manufacturer Contact
jim vegel
MDR Report Key16722236
MDR Text Key313113543
Report Number3012307300-2023-03927
Device Sequence Number1
Product Code LGZ
UDI-Device Identifier50695085820909
UDI-Public50695085820909
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,Followup
Report Date 06/02/2023
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 NumberHL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/21/2023
Initial Date FDA Received04/12/2023
Supplement Dates Manufacturer Received05/22/2023
Supplement Dates FDA Received06/01/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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