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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL LEVEL 1 HOTLINE 3 BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID
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NULL LEVEL 1 HOTLINE 3 BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-390
Device Problem Failure to Power Up (1476)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Other, other text: one level 1 hotline 3 blood and fluid warmer was returned for analysis.Wear and tear were observed to the enclosure, front cover, tank cover and the line cord upon visual inspection.The pcb and power switch were found to be outdated.The tank was filled with water, temp check was attached, line cord was plugged in and the unit was powered on; confirming the complaint of no power.Based on the evidence, the root cause was found due to design.
 
Event Description
Information was received indicating that a smiths medical level 1 hotline 3 blood and fluid warmer would not power on.There were no reported adverse effects.
 
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Brand Name
LEVEL 1 HOTLINE 3 BLOOD AND FLUID WARMER
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section G)
NULL
MDR Report Key10066481
MDR Text Key191293309
Report Number3012307300-2020-04523
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Reporter Country CodeUS
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 05/18/2020
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 No Information
Device Model NumberHL-390
Device Catalogue NumberCON-HL-390
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/21/2020
Initial Date FDA Received05/18/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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