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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 ACCESSORY SYSTEM, THERMAL REGULATING

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SMITHS MEDICAL ASD; INC. LEVEL 1® EQUATOR® CONVECTIVE WARMING ACCESSORY SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number SW5-HOSE-7
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Event Type  malfunction  
Manufacturer Narrative
Report source: (b)(6).
 
Event Description
Information was received indicating that a smiths medical level 1® equator® convective warming device burned a patient. There were no reported further adverse effects.
 
Manufacturer Narrative
Additional information was received indicating that second degree and third degree burns were noted to the patient's toes following use of a level 1® equator® convective warming hose. The patient was reported to have been lying flat on his back during the procedure. Jelonet dressings and flammazine cream were used for the treatment of the burns. Prolonged sedation and immobilization with extended hospital stay was reported. There was no further reported adverse effects.
 
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Brand NameLEVEL 1® EQUATOR® CONVECTIVE WARMING ACCESSORY
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 Key8693926
MDR Text Key147871976
Report Number3012307300-2019-03205
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K011907
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,Followup
Report Date 03/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSW5-HOSE-7
Device Lot NumberN2072
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/20/2017
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: 06/12/2019 Patient Sequence Number: 1
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