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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. EQUATOR CONVECTIVE WARMING SYSTEM SYSTEM, THERMAL REGULATING

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SMITHS MEDICAL ASD, INC. EQUATOR CONVECTIVE WARMING SYSTEM SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number EQ-5000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Event Date 01/13/2016
Event Type  Injury  
Manufacturer Narrative
Smiths medical has received the sample device. A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site. Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.
 
Event Description
Distributor reported the device was in use with patient at 36 degree setting during procedure lasting approximately 30 minutes. After the procedure, burns were noticed on the patient's skin. The level of burns were reported to be of 1st or 2nd degree burns. No further intervention or adverse effects to patient reported. The convective warmer was in use with upper body warming blanket (part number (b)(4)). The device did not alarm and kept running during the entire procedure.
 
Manufacturer Narrative
One used warming device, warming hose, and warming blanket were returned for investigation. The original power cord was not returned. Visual inspection observed that the warming hose that was returned was not the original factory calibrated hose that was supplied with the unit. A few blemishes were observed on the warming device housing. The blanket was visually inspected; all perforations were present and the seals intact. During functional testing, the returned accessories were assembled to the warming device and the device was turned on. The device performed its self-test with no issues observed. The device was set to each of its three different temperature settings; all temperatures were found within specification. The warming device was forced into over temperature at each temperature setting. During all three forced overheating simulations, the alarm sounded and the warming device shut itself off as intended. The reported product problem could not be duplicated as the returned device and accessories operated in specification with no faults found.
 
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Brand NameEQUATOR CONVECTIVE WARMING SYSTEM
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
160 weymouth street
rockland MA 02370
Manufacturer (Section G)
SMITHS MEDICAL ASD INC.,
1265 grey fox road
st paul MN 55112
Manufacturer Contact
michele seliga
1265 grey fox rd.
st. paul, MN 55112
7633833052
MDR Report Key5410226
MDR Text Key37463121
Report Number2183502-2016-00138
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K011907
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
Report Date 02/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberEQ-5000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/03/2007
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: 02/04/2016 Patient Sequence Number: 1
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