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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE; SYSTEM, THERMAL REGULATING
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SMITHS MEDICAL ASD, INC. LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE; SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number SW5-HOSE-7
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Superficial (First Degree) Burn (2685)
Event Date 07/28/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a patient sustained a first degree burn on the left forearm with the use of a level 1® equator® hose with thermistor.This was after 4 hours and 30 minutes of use of the device.The patient was positioned in a supine position with the arms crossed.The operating temperature was 40 degrees celsius.Clinicians ensured that the installation was non-compressive.No other adverse health outcomes were reported.
 
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Brand Name
LEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE
Type of Device
SYSTEM, THERMAL REGULATING
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD INC.
1265 grey fox road
st. paul MN 55112
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key6831141
MDR Text Key83993688
Report Number3012307300-2017-01976
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier50695085000653
UDI-Public50695085000653
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011907
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Reporter Occupation Other
Type of Report Initial
Report Date 08/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberSW5-HOSE-7
Device Lot NumberN2067
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2017
Was the Report Sent to FDA? No
Date Manufacturer Received08/14/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/07/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
LEVEL 1® EQUATOR® CONVECTIVE WARMER; LEVEL 1® SNUGGLE WARM® BLANKET
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