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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 EQ-5000-JP-100VE
Device Problems Fire (1245); Smoking (1585)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/21/2018
Event Type  malfunction  
Event Description
Information was received that the equator product had smoke at the power cable.No reported adverse effects.
 
Manufacturer Narrative
One convective warmer received with power cord for evaluation.When cover was removed, the odor of smoke was present.Observed where mains input and also power cord plug end were melted.There was no evidence of blown fuses on the mains board.Found no evidence of charring at the end of the line filter.Heat damage was localized to power cord and mains input.This is most probably caused by fluid ingression while device is drawing power.Customer complaint was confirmed.This investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.
 
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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 Contact
1265 grey fox road
st. paul, MN 55112
MDR Report Key7615515
MDR Text Key111542007
Report Number3012307300-2018-02463
Device Sequence Number1
Product Code DWJ
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,Followup
Report Date 11/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberEQ-5000-JP-100VE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/20/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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