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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 Thermal Decomposition of Device (1071); Fire (1245)
Patient Problem No Patient Involvement (2645)
Event Date 03/21/2020
Event Type  malfunction  
Event Description
Information was received indicating that the filter to a smiths medical level 1 equator convective warming device was found to have severe thermal deformation. It was reported that the cause of the filter damage was from thermal heating or possible fire. 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 n
minneapolis, mn
Manufacturer (Section G)
SMITHS MEDICAL ASD; INC
6000 nathan lane n
minneapolis, mn
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis, mn 
3833310
MDR Report Key10017000
MDR Text Key189577906
Report Number3012307300-2020-03579
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5000
Device Catalogue NumberEQ-5000-DE-230V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/21/2011
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: 05/01/2020 Patient Sequence Number: 1
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