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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.
 
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Brand NameLEVEL 1® EQUATOR® CONVECTIVE WARMING DEVICE
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, MN 55442
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis,, MN 55442
7633833310
MDR Report Key8843726
MDR Text Key152745544
Report Number3012307300-2019-03894
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Biomedical Engineer
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
Device Model Number5000
Device Catalogue NumberEQ-5000-FR-230V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/24/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/30/2019 Patient Sequence Number: 1
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