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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. LEVEL 1 H-1200 LOW FLOW FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

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SMITHS MEDICAL ASD; INC. LEVEL 1 H-1200 LOW FLOW FLUID WARMER; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-90
Device Problems Leak/Splash (1354); Device Fell (4014)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical level 1® h-1200 low flow fluid warmer was dropped and that the case was found leaking afterward.There were no reported adverse effects.
 
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Brand Name
LEVEL 1 H-1200 LOW FLOW FLUID WARMER
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis,, mn
Manufacturer (Section G)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis,, mn
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis,, mn 
3833310
MDR Report Key9821033
MDR Text Key183086617
Report Number3012307300-2020-01931
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 03/11/2020
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-90
Device Catalogue NumberCON-HL-90
Device Lot NumberS10006160
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/12/2020
Initial Date FDA Received03/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/26/2010
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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