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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 Problem Temperature Problem (3022)
Patient Problems Erythema (1840); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Event Date 07/01/2019
Event Type  Injury  
Event Description
Information was received indicating that upon removal of a smiths medical level 1® equator® convective warming blower erythema was noted to the patient's arm, forearm, chest and abdomen. The right forearm was reported to show the beginning of phlycten. The clinician stated that the patient was well positioned on the blanket without any external constraint. The warmer was reported to set to 44 degrees celsius but the display had read 37 degrees celsius. Subsequently, biafine was prescribed for dressings. There were no further reported adverse effects.
 
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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 Key8843571
MDR Text Key152711424
Report Number3012307300-2019-03892
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 03/05/2020
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 Received02/04/2020
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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