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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; WARMER, THERMAL, INFUSION FLUID
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SMITHS MEDICAL ASD; INC. LEVEL 1 FAST FLOW FLUID WARMER; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number H1000
Device Problem Intermittent Loss of Power (4016)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/21/2019
Event Type  malfunction  
Event Description
Information was received indicating that the over temperature alarm to a smiths medical level 1® fast flow fluid warmer continued to be activated despite repeated powering on and off.It was reported that the disposable was attached and sterile water was in the reservoir.There were no reported adverse effects.
 
Manufacturer Narrative
Evaluation results: one level 1 trauma fast flow system was returned for investigation in used condition.Visual inspection did not reveal any damage.The investigator subsequently filled the tank with water, attached a temp-check, plugged in the line cord, and turned on the power switch.The customer reported product problem (activation of the over temperature alarm) was not confirmed during testing.No fault was found with the device.The problem source of the reported product problem was unknown.A root cause was not established.
 
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Brand Name
LEVEL 1 FAST FLOW FLUID WARMER
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, mn
MDR Report Key10028849
MDR Text Key190001619
Report Number3012307300-2019-05148
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 company representative,foreig
Type of Report Initial,Followup
Report Date 05/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberH1000
Device Catalogue NumberH-1000-UK-230
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2020
Date Manufacturer Received04/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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