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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 L1-CW-220V
Device Problem Temperature Problem (3022)
Patient Problem No Information (3190)
Event Date 01/01/1901
Event Type  malfunction  
Manufacturer Narrative
Phone number provided by customer: (b)(6).
 
Event Description
Information was received indicating that during preventative maintenance of a smiths medical level 1 equator convective warming device burn marks were found to the inside of the heater housing. It was reported the outgoing air smelled burnt. There were no 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 north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key10011581
MDR Text Key189444327
Report Number3012307300-2020-03488
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberL1-CW-220V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/05/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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