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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC. FLUID WARMING LEVEL 1 NORMOFLO IRRIGATION FAST FLOW SYSTEMS - H-1100 SERIES; WARMER, THERMAL, INFUSION FLUID
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SMITHS MEDICAL ASD,INC. FLUID WARMING LEVEL 1 NORMOFLO IRRIGATION FAST FLOW SYSTEMS - H-1100 SERIES; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HOTLINE
Device Problems Electrical /Electronic Property Problem (1198); Overheating of Device (1437)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical fluid warming|level 1 hotline were leaving puddles of soft gray rubber under the warmers.The feet can be rubbed off the bottom of the warmer with paper towel and referenced like chocolate.The feet are melting on the floor beneath the unit.No adverse patient events reported.
 
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Brand Name
FLUID WARMING LEVEL 1 NORMOFLO IRRIGATION FAST FLOW SYSTEMS - H-1100 SERIES
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
SMITHS MEDICAL ASD,INC.
6000 nathan lane north
minneapolis, mn
Manufacturer (Section G)
SMITHS MEDICAL ASD,INC
6000 lane n
minneapolis, mn
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, mn 
3833310
MDR Report Key10235448
MDR Text Key197676407
Report Number3012307300-2020-06653
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 06/06/2020
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 Other
Device Model NumberHOTLINE
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/08/2020
Initial Date FDA Received07/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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