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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
Model Number 5000
Device Problems Temperature Problem (3022); Excessive Heating (4030)
Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Event Date 07/01/2019
Event Type  Injury  
Event Description
Information was received indicating that following use of a smiths medical level 1® equator® convective warming blower phlycten was noted to the patient's right forearm.Subsequently, vaseline gauze and biafine cream was applied to the burn.No further adverse patient effects were reported.
 
Manufacturer Narrative
Investigaiton results completed on a convective warming|level 1 equator blowers.The complaint reported patient burns.The device arrived and the physical condition revealed wear and tear with damages on top and bottom enclosures, along with oil leaking on motor.Device was powered on and on the key pad ran high, medium and low for two hours.No overheating occurred.The over heating was not able to be duplicated and no problem found.Prevenative messures were implemented to replace enclosure top and bottom, motor, impeller, heater and hose.The device passed all functinal and delivery testing.
 
Event Description
Device analysis completed and will be summarized.
 
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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 n
minneapolis, MN 55442
MDR Report Key8843726
MDR Text Key152745544
Report Number3012307300-2019-03894
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number5000
Device Catalogue NumberEQ-5000-FR-230V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2019
Date Manufacturer Received07/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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