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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID, PRODUCT CODE: LGZ
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SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID, PRODUCT CODE: LGZ Back to Search Results
Catalog Number CON-HL-90
Device Problems Failure to Power Up (1476); Power Problem (3010); Complete Loss of Power (4015)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Information was received that a smiths medical level 1 hotline blood and fluid warmer had "no power".No adverse patient effects were reported.
 
Manufacturer Narrative
Additional information: d10, h6, h10.Device evaluation: one smiths medical level 1 hotline blood and fluid warmer was returned for analysis with cracks around bolts on the reservoir tank, damaged display label, bent in power switch, corroded drain fitting and a crack on the enclosure underneath it and worn line cord.During analysis, the reported problem was able to be duplicated.It was noted that the power switch was bent and was the cause of the reported issue.Based on the evidence, the complaint was confirmed, and the problem source of the reported event was noted to be design.
 
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Brand Name
LEVEL 1 HOTLINE BLOOD AND FLUID WARMER
Type of Device
WARMER, THERMAL, INFUSION FLUID, PRODUCT CODE: LGZ
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key9650383
MDR Text Key177374187
Report Number3012307300-2020-00614
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 04/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2020
Date Manufacturer Received03/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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