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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-390
Device Problems Image Display Error/Artifact (1304); Output Problem (3005)
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 a "bad lcd".No patient involvement.
 
Manufacturer Narrative
One fluid warmer was returned for evaluation.Visual inspection of the device found nothing displayed on lcd, wear and tear damage to enclosure, front cover, and line cord.A dhr review was performed subsequent to the manufacturing of the device and prior to its release; no problems were identified during this dhr review.Device underwent functional testing by filling tank with water and powering it on.The reported customer complaint has been confirmed as a result of a faulty pcb.The problem source however has been determined to be unknown.
 
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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
MDR Report Key9767263
MDR Text Key181341378
Report Number3012307300-2020-01589
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 04/24/2020
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 Catalogue NumberCON-HL-390
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2020
Initial Date Manufacturer Received 01/30/2020
Initial Date FDA Received02/27/2020
Supplement Dates Manufacturer Received03/26/2020
Supplement Dates FDA Received04/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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