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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. LEVEL 1 FAST-FLOW FLUID WARMER ACCESSORIES; WARMER, THERMAL, INFUSION FLUID
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SMITHS MEDICAL ASD; INC. LEVEL 1 FAST-FLOW FLUID WARMER ACCESSORIES; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Catalog Number 7012701
Device Problem Complete Loss of Power (4015)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/26/2019
Event Type  malfunction  
Event Description
Information was received indicating that electronic assembly to a smiths medical level 1® fast-flow fluid warmer was not providing power.There were no reported adverse effects.
 
Manufacturer Narrative
Evaluation results: the electronic assembly, an accessory of the level 1 trauma fast flow system, was returned for investigation in used condition.Visual inspection did not reveal any physical damage.The investigator performed a power on self-test.The customer reported product problem (not providing power) was confirmed during testing.The investigator noted that due to a faulty main pcb, they were unable to adjust the over temperature potentiometer. the pcb was therefore scrapped.
 
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Brand Name
LEVEL 1 FAST-FLOW FLUID WARMER ACCESSORIES
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, MN 55442
MDR Report Key9613571
MDR Text Key175869176
Report Number3012307300-2020-00315
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 06/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number7012701
Device Lot NumberP0726123
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2020
Date Manufacturer Received05/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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